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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 settembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

799

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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).
Droga: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Sperimentale: 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).
Droga: 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
Altri nomi:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Sperimentale: 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).
Droga: 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
Altri nomi:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Sperimentale: 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).
Droga: 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
Altri nomi:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Sperimentale: 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).
Droga: 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
Altri nomi:
  • FE992026
  • Nocturin®
  • Minirin® Melt

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Lasso di tempo: - 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
Lasso di tempo: - 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ferring Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2007

Completamento primario (Effettivo)

1 febbraio 2008

Completamento dello studio (Effettivo)

1 febbraio 2008

Date di iscrizione allo studio

Primo inviato

22 maggio 2007

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2007

Primo Inserito (Stima)

23 maggio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FE992026 CS29

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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