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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29. september 2015 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
799

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Placebo komparator: 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).
Medicin: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentel: 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).
Medicin: 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
Andre navne:
  • FE992026
  • Nocturin®
  • Minirin® Smelt

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Tidsramme: - 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
Tidsramme: - 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)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: - 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Ferring Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. maj 2007

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. februar 2008

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. februar 2008

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
22. maj 2007

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. maj 2007

Først opslået (Skøn)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
23. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
1. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
29. september 2015

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • FE992026 CS29

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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