- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00915525
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
18. dubna 2019 aktualizováno: Allergan
The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
829
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Gent, Belgie
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British Columbia
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Victoria, British Columbia, Kanada
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Tubingen, Německo
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Warsaw, Polsko
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Moscow, Ruská Federace
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London, Spojené království
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California
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Newport Beach, California, Spojené státy
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Prague, Česko
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
Exclusion Criteria:
- Females who are pregnant, nursing or planning a pregnancy
- Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: botulinum toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
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Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Ostatní jména:
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Experimentální: botulinum toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
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Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 2
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 3
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 4
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 5
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Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
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Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of incontinence episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 6
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Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
Časové okno: Week 12 Treatment Cycle 1
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The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 1
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Percentage of Patients With a Positive Response on the 4-Point TBS
Časové okno: Week 12 Treatment Cycle 2
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The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 2
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Percentage of Patients With a Positive Response on the 4-Point TBS
Časové okno: Week 12 Treatment Cycle 3
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The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 3
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Percentage of Patients With a Positive Response on the 4-Point TBS
Časové okno: Week 12 Treatment Cycle 4
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The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 4
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Percentage of Patients With a Positive Response on the 4-Point TBS
Časové okno: Week 12 Treatment Cycle 5
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The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 5
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Percentage of Patients With a Positive Response on the 4-Point TBS
Časové okno: Week 12 Treatment Cycle 6
|
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520.
Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened.
Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
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Week 12 Treatment Cycle 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
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The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
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The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 2
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
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The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 3
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 4
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
|
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 5
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Change From Study Baseline in the Daily Average Number of Micturition Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
|
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of micturition episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
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Study Baseline, Week 12 Treatment Cycle 6
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Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
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Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 2
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 3
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 4
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Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
|
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives.
Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL).
The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL).
The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment.
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 1
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Change From Study Baseline in the KHQ Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the KHQ Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the KHQ Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the KHQ Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the KHQ Role Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in the KHQ Social Limitations Domain
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
|
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence.
The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot).
The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520.
Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
|
Study Baseline, Week 12 Treatment Cycle 6
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 1
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 1
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 2
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 2
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 3
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 3
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 4
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 4
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 5
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 5
|
Change From Study Baseline in Daily Frequency of Urgency Episodes
Časové okno: Study Baseline, Week 12 Treatment Cycle 6
|
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520).
The number of urgency episodes are averaged daily during this period.
The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520.
A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
|
Study Baseline, Week 12 Treatment Cycle 6
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. února 2010
Primární dokončení (Aktuální)
5. srpna 2014
Dokončení studie (Aktuální)
5. srpna 2014
Termíny zápisu do studia
První předloženo
28. května 2009
První předloženo, které splnilo kritéria kontroly kvality
4. června 2009
První zveřejněno (Odhad)
8. června 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Symptomy chování
- Duševní poruchy
- Urologická onemocnění
- Onemocnění močového měchýře
- Příznaky dolních močových cest
- Urologické projevy
- Poruchy močení
- Poruchy eliminace
- Močový měchýř, hyperaktivní
- Únik moči
- Enuréza
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Agenti periferního nervového systému
- Cholinergní činidla
- Membránové transportní modulátory
- Inhibitory uvolňování acetylcholinu
- Neuromuskulární látky
- Botulotoxiny
- Botulotoxiny typu A
- abobotulinumtoxinA
Další identifikační čísla studie
- 191622-096
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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