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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 de setembro de 2015 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

799

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de 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).
Medicamento: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Experimental: 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).
Medicamento: 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
Outros nomes:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimental: 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).
Medicamento: 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
Outros nomes:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimental: 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).
Medicamento: 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
Outros nomes:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimental: 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).
Medicamento: 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
Outros nomes:
  • FE992026
  • Nocturin®
  • Minirin® Melt

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Prazo: - 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
Prazo: - 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: - 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ferring Pharmaceuticals

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2007

Conclusão Primária (Real)

1 de fevereiro de 2008

Conclusão do estudo (Real)

1 de fevereiro de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

22 de maio de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de maio de 2007

Primeira postagem (Estimativa)

23 de maio de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de novembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2015

Última verificação

1 de setembro de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FE992026 CS29

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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