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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29. september 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

799

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
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).
Legemiddel: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Eksperimentell: 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).
Legemiddel: 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 navn:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentell: 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).
Legemiddel: 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 navn:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentell: 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).
Legemiddel: 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 navn:
  • FE992026
  • Nocturin®
  • Minirin® Smelt
Eksperimentell: 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).
Legemiddel: 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 navn:
  • FE992026
  • Nocturin®
  • Minirin® Smelt

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ferring Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2007

Primær fullføring (Faktiske)

1. februar 2008

Studiet fullført (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først innsendt

22. mai 2007

Først innsendt som oppfylte QC-kriteriene

22. mai 2007

Først lagt ut (Anslag)

23. mai 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FE992026 CS29

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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