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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 сентября 2015 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

799

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: 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).
Лекарство: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Экспериментальный: 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).
Лекарство: 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
Другие имена:
  • FE992026
  • Ноктурин®
  • Минирин® Расплав
Экспериментальный: 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).
Лекарство: 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
Другие имена:
  • FE992026
  • Ноктурин®
  • Минирин® Расплав
Экспериментальный: 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).
Лекарство: 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
Другие имена:
  • FE992026
  • Ноктурин®
  • Минирин® Расплав
Экспериментальный: 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).
Лекарство: 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
Другие имена:
  • FE992026
  • Ноктурин®
  • Минирин® Расплав

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Временное ограничение: - 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
Временное ограничение: - 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: - 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Ferring Pharmaceuticals

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 мая 2007 г.

Первичное завершение (Действительный)

1 февраля 2008 г.

Завершение исследования (Действительный)

1 февраля 2008 г.

Даты регистрации исследования

Первый отправленный

22 мая 2007 г.

Впервые представлено, что соответствует критериям контроля качества

22 мая 2007 г.

Первый опубликованный (Оценивать)

23 мая 2007 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

1 ноября 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 сентября 2015 г.

Последняя проверка

1 сентября 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • FE992026 CS29

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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