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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

2015년 9월 29일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

799

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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).
의약품: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
실험적: 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).
의약품: 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
다른 이름들:
  • FE992026
  • 녹투린®
  • Minirin® 용융물
실험적: 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).
의약품: 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
다른 이름들:
  • FE992026
  • 녹투린®
  • Minirin® 용융물
실험적: 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).
의약품: 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
다른 이름들:
  • FE992026
  • 녹투린®
  • Minirin® 용융물
실험적: 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).
의약품: 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
다른 이름들:
  • FE992026
  • 녹투린®
  • Minirin® 용융물

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
기간: - 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
기간: - 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
기간: - 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
기간: - 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
기간: - 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
기간: - 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
기간: - 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
기간: - 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
기간: - 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
기간: - 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ferring Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 5월 1일

기본 완료 (실제)

2008년 2월 1일

연구 완료 (실제)

2008년 2월 1일

연구 등록 날짜

최초 제출

2007년 5월 22일

QC 기준을 충족하는 최초 제출

2007년 5월 22일

처음 게시됨 (추정)

2007년 5월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 9월 29일

마지막으로 확인됨

2015년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FE992026 CS29

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cambodia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다