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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29. září 2015 aktualizováno: Ferring Pharmaceuticals

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

799

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

  • Kanada
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1Y-2H4
        • Southern Interior Medical Center
      • Victoria, British Columbia, Kanada, V8T 5G1
        • Can-Med Clinical Research Inc.
      • Victoria, British Columbia, Kanada, V8V 3N1
        • Investigational site - Clinical Research
    • New Brunswick
      • Fredericton, New Brunswick, Kanada, E3B 5B8
        • Investigational site - Professional Corporation
    • Ontario
      • Barrie, Ontario, Kanada, L4M 7G1
        • The Male/Female Health and Reserach
      • Brantford, Ontario, Kanada, N3R 4N3
        • Brantford Urology Research
      • Guelph, Ontario, Kanada, N1H 5J1
        • Guelph Urology Associates
      • North Bay, Ontario, Kanada, P1B 4Z2
        • Investigational Site
      • Oakville, Ontario, Kanada, L6H 3P1
        • The Fe/Male Health Centres
      • Toronto, Ontario, Kanada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35209
        • Radiant Research
    • Arizona
      • Scottsdale, Arizona, Spojené státy, 85251
        • Radiant Research
    • Arkansas
      • Little Rock, Arkansas, Spojené státy, 72204
        • Arkansas Primary Care Clinic
    • California
      • Anaheim, California, Spojené státy, 92801
        • Advanced Urology Medical Center
      • Beverly Hills, California, Spojené státy, 90211
        • Impact Clinical Trials
      • Long Beach, California, Spojené státy, 90806
        • Atlantic Urology Medical Group
      • Newport Beach, California, Spojené státy, 92660
        • California Professional Research
      • San Diego, California, Spojené státy, 92103
        • San Diego Uro-Research
      • Santa Rosa, California, Spojené státy, 95404
        • Radiant Research
      • Tarzana, California, Spojené státy, 91356
        • West Coast Clinical Research
      • Torrance, California, Spojené státy, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, Spojené státy, 80218
        • Downtown Women's Health Care
      • Denver, Colorado, Spojené státy, 80220
        • Genitourinary Surgical Consultants
      • Denver, Colorado, Spojené státy, 80210
        • Urology Associates PC
    • Connecticut
      • Middlebury, Connecticut, Spojené státy, 06762
        • Connecticut Clinical Research Center, LLC
    • Florida
      • Aventura, Florida, Spojené státy, 33180
        • South Florida Medical Research
      • Clearwater, Florida, Spojené státy, 33759
        • Women's Medical Research Group, LLC
      • Miami, Florida, Spojené státy, 33145
        • Medsearch Professional Group
      • Plantation, Florida, Spojené státy, 33324
        • Sunrise Medical Research
      • Stuart, Florida, Spojené státy, 34996
        • Radiant Research
      • Tallahassee, Florida, Spojené státy, 32308
        • Southeastern Research Group, Inc.
      • Tampa, Florida, Spojené státy, 33607
        • Tampa Bay Urology
      • West Palm Beach, Florida, Spojené státy, 33407
        • Radiant Research
    • Georgia
      • Columbus, Georgia, Spojené státy, 31904
        • Southeastern Medical Research Institute
      • Dunwoody, Georgia, Spojené státy, 30338
        • Investigational site - PC
    • Illinois
      • Peoria, Illinois, Spojené státy, 61602
        • Accelovance
    • Kansas
      • Overland park, Kansas, Spojené státy, 66202
        • Radiant Research, Kansas City
    • Louisiana
      • Metairie, Louisiana, Spojené státy, 70006
        • Benchmark Research
      • Shreveport, Louisiana, Spojené státy, 71106
        • Regional Urology, LLC
      • Shreveport, Louisiana, Spojené státy, 71111
        • Pierremont Women's Clinic
    • Massachusetts
      • Springfield, Massachusetts, Spojené státy, 01103
        • FutureCare Studies, Inc.
    • Missouri
      • St. Louis, Missouri, Spojené státy, 63141
        • Radiant Research Inc.
    • Nebraska
      • Lincoln, Nebraska, Spojené státy, 68510
        • Women's Clinic of Lincoln, P.C
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89109
        • Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Spojené státy, 08648
        • Lawrenceville Urology
      • Lawrenceville, New Jersey, Spojené státy, 08648
        • AdvanceMed Research
      • Morristown, New Jersey, Spojené státy, 07960
        • Morristown Urology
    • New Mexico
      • Albuquerque, New Mexico, Spojené státy, 87109
        • Urology Group of New Mexico, PC
    • New York
      • Albany, New York, Spojené státy, 12206
        • Upstate Urology
      • Carmel, New York, Spojené státy, 10512
        • Investigational site - Adult & Pediatric Urology
      • Garden City, New York, Spojené státy, 11530
        • AccuMed Research Associates
      • New York, New York, Spojené státy, 10016
        • University Urology Associates
      • Suffern, New York, Spojené státy, 10901
        • Ferring Pharmaceutical Inc
    • North Carolina
      • Concord, North Carolina, Spojené státy, 28025
        • Northeast Urology Research
      • Greensboro, North Carolina, Spojené státy, 27401
        • PharmQuest
      • Wilmington, North Carolina, Spojené státy, 28401
        • New Hanover Medical Research
      • Winston-Salem, North Carolina, Spojené státy, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45249
        • Radiant Research
      • Mogadore, Ohio, Spojené státy, 44260
        • Radiant Research - Akron
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, Spojené státy, 19004
        • Urologic Consultants of SE PA
      • Philadelphia, Pennsylvania, Spojené státy, 19115
        • Radiant Research
      • Philadelphia, Pennsylvania, Spojené státy, 19114
        • Philadelphia Clinical Research, LLC
      • Reading, Pennsylvania, Spojené státy, 19611
        • Advanced Clinical Concepts
    • South Carolina
      • Greenville, South Carolina, Spojené státy, 29605
        • University Medical Group
      • Greer, South Carolina, Spojené státy, 29651
        • Radiant Research, Greer
      • Mt. Pleasant, South Carolina, Spojené státy, 29464
        • Palmetto Medical Research
      • Myrtle Beach, South Carolina, Spojené státy, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Kingsport, Tennessee, Spojené státy, 37660
        • Holston Medical Group
      • Nashville, Tennessee, Spojené státy, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, Spojené státy, 78414
        • Advanced Research Associates
      • Dallas, Texas, Spojené státy, 75231
        • Health Central Women's Care
      • Houston, Texas, Spojené státy, 77024
        • Accelovance
      • Humble, Texas, Spojené státy, 77338
        • Regional Medical Center and Diagnostic
      • San Antonio, Texas, Spojené státy, 78229
        • Urology San Antonio Research, PA
      • San Antonio, Texas, Spojené státy, 78228
        • Radiant Research San Antonio
    • Virginia
      • Richmond, Virginia, Spojené státy, 23235
        • Virginia Urology Center
      • Virginia Beach, Virginia, Spojené státy, 23454
        • Urology of Virginia PC
    • Washington
      • Seattle, Washington, Spojené státy, 98105
        • Women's Clinical Research Center
      • Seattle, Washington, Spojené státy, 98166
        • Seattle Urology Research Center
      • Seattle, Washington, Spojené státy, 98166
        • Investigational site - Medical Professional

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

  1. Written informed consent prior to the performance of any study-related activity.
  2. Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day frequency-volume chart during the screening period.

Exclusion Criteria:

Males:

  1. Clinical suspicion of bladder outlet obstruction and/or urine flow < 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis

  2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months

    Females:

  3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
  4. Use of pessary for pelvic prolapse.

  5. Unexplained pelvic mass.

    Males and Females:

  6. Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
  7. Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
  8. Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
  9. History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
  10. Suspicion or evidence of cardiac failure.
  11. Uncontrolled hypertension.
  12. Uncontrolled diabetes mellitus.
  13. Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) >=60 mL/min.
  14. Active hepatic and/or biliary disease. Aspartate transaminase (AST) or alanine transaminase (ALT) should not be >2 times the upper limit of normal. Total bilirubin should not be > 1.5 mg/dL.
  15. Hyponatremia. Serum sodium level must be within normal limits
  16. Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
  17. Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
  18. Psychogenic or habitual polydipsia

  19. Obstructive sleep apnea

    Other

  20. Known alcohol or substance abuse
  21. Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
  22. Previous desmopressin treatment for nocturia.
  23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity or language barrier that, in the judgment of the investigator, could impair patient participation in the trial.
  24. Use of loop diuretics (furosemide, torsemide, ethacrynic acid). Other classes of diuretics (thiazides, triamterene, chlorthalidone, amiloride, indapamide) were permitted, either as monotherapy or combination therapy. Subjects using a diuretic were to be encouraged to take it in the morning, if medically feasible.
  25. Use of any other investigational drug within 30 days of screening.

Concomitant Medications

The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i.e. treatment has not been initiated or discontinued and there has been no change in dose):

  • Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin); Uroxatral (alfuzosin)
  • 5 alpha-reductase inhibitors: Avodart (dutasteride); Proscar (finasteride)
  • Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder: Detrol, Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)
  • Sedative/hypnotic medications for sleep disorders
  • Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa (citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)
  • Chronic use of nonsteroidal anti-inflammatory agents
  • Diabinese (chlorpropamide)
  • Carbamazepine (carbatrol/tegretol)
  • Amiodarone

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: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Lék: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Experimentální: desmopressin melt 10 μg
Participants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Lék: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Ostatní jména:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimentální: desmopressin melt 25 μg
Participants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Lék: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Ostatní jména:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimentální: desmopressin melt 50 μg
Participants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Lék: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Ostatní jména:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimentální: desmopressin melt 100 μg
Participants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Lék: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Ostatní jména:
  • FE992026
  • Nocturin®
  • Minirin® Melt

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.

This was the first co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.

This was the second co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Časové okno: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Časové okno: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part I: Change From Baseline in Total Reported Sleep Time at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Total sleep time was recorded by participants in study diaries.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4
Časové okno: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Časové okno: Day 1 up to Week 4 (end of Part I)
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Day 1 up to Week 4 (end of Part I)
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Časové okno: Week 5 up to Day 169
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Week 5 up to Day 169

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ferring Pharmaceuticals

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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

1. května 2007

Primární dokončení (Aktuální)

1. února 2008

Dokončení studie (Aktuální)

1. února 2008

Termíny zápisu do studia

První předloženo

22. května 2007

První předloženo, které splnilo kritéria kontroly kvality

22. května 2007

První zveřejněno (Odhad)

23. května 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

1. listopadu 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. září 2015

Naposledy ověřeno

1. září 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • FE992026 CS29

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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