Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
2015年9月29日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
799
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35209
- Radiant Research
-
-
Arizona
-
Scottsdale、Arizona、アメリカ、85251
- Radiant Research
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72204
- Arkansas Primary Care Clinic
-
-
California
-
Anaheim、California、アメリカ、92801
- Advanced Urology Medical Center
-
Beverly Hills、California、アメリカ、90211
- Impact Clinical Trials
-
Long Beach、California、アメリカ、90806
- Atlantic Urology Medical Group
-
Newport Beach、California、アメリカ、92660
- California Professional Research
-
San Diego、California、アメリカ、92103
- San Diego Uro-Research
-
Santa Rosa、California、アメリカ、95404
- Radiant Research
-
Tarzana、California、アメリカ、91356
- West Coast Clinical Research
-
Torrance、California、アメリカ、90505
- Western Clinical Research
-
-
Colorado
-
Denver、Colorado、アメリカ、80218
- Downtown Women's Health Care
-
Denver、Colorado、アメリカ、80220
- Genitourinary Surgical Consultants
-
Denver、Colorado、アメリカ、80210
- Urology Associates PC
-
-
Connecticut
-
Middlebury、Connecticut、アメリカ、06762
- Connecticut Clinical Research Center, LLC
-
-
Florida
-
Aventura、Florida、アメリカ、33180
- South Florida Medical Research
-
Clearwater、Florida、アメリカ、33759
- Women's Medical Research Group, LLC
-
Miami、Florida、アメリカ、33145
- Medsearch Professional Group
-
Plantation、Florida、アメリカ、33324
- Sunrise Medical Research
-
Stuart、Florida、アメリカ、34996
- Radiant Research
-
Tallahassee、Florida、アメリカ、32308
- Southeastern Research Group, Inc.
-
Tampa、Florida、アメリカ、33607
- Tampa Bay Urology
-
West Palm Beach、Florida、アメリカ、33407
- Radiant Research
-
-
Georgia
-
Columbus、Georgia、アメリカ、31904
- Southeastern Medical Research Institute
-
Dunwoody、Georgia、アメリカ、30338
- Investigational site - PC
-
-
Illinois
-
Peoria、Illinois、アメリカ、61602
- Accelovance
-
-
Kansas
-
Overland park、Kansas、アメリカ、66202
- Radiant Research, Kansas City
-
-
Louisiana
-
Metairie、Louisiana、アメリカ、70006
- Benchmark Research
-
Shreveport、Louisiana、アメリカ、71106
- Regional Urology, LLC
-
Shreveport、Louisiana、アメリカ、71111
- Pierremont Women's Clinic
-
-
Massachusetts
-
Springfield、Massachusetts、アメリカ、01103
- FutureCare Studies, Inc.
-
-
Missouri
-
St. Louis、Missouri、アメリカ、63141
- Radiant Research Inc.
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68510
- Women's Clinic of Lincoln, P.C
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89109
- Investigational Site
-
-
New Jersey
-
Lawrenceville、New Jersey、アメリカ、08648
- Lawrenceville Urology
-
Lawrenceville、New Jersey、アメリカ、08648
- AdvanceMed Research
-
Morristown、New Jersey、アメリカ、07960
- Morristown Urology
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87109
- Urology Group of New Mexico, PC
-
-
New York
-
Albany、New York、アメリカ、12206
- Upstate Urology
-
Carmel、New York、アメリカ、10512
- Investigational site - Adult & Pediatric Urology
-
Garden City、New York、アメリカ、11530
- AccuMed Research Associates
-
New York、New York、アメリカ、10016
- University Urology Associates
-
Suffern、New York、アメリカ、10901
- Ferring Pharmaceutical Inc
-
-
North Carolina
-
Concord、North Carolina、アメリカ、28025
- Northeast Urology Research
-
Greensboro、North Carolina、アメリカ、27401
- PharmQuest
-
Wilmington、North Carolina、アメリカ、28401
- New Hanover Medical Research
-
Winston-Salem、North Carolina、アメリカ、27103
- Piedmont Medical Research Associates
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45249
- Radiant Research
-
Mogadore、Ohio、アメリカ、44260
- Radiant Research - Akron
-
-
Pennsylvania
-
Bala Cynwyd、Pennsylvania、アメリカ、19004
- Urologic Consultants of SE PA
-
Philadelphia、Pennsylvania、アメリカ、19115
- Radiant Research
-
Philadelphia、Pennsylvania、アメリカ、19114
- Philadelphia Clinical Research, LLC
-
Reading、Pennsylvania、アメリカ、19611
- Advanced Clinical Concepts
-
-
South Carolina
-
Greenville、South Carolina、アメリカ、29605
- University Medical Group
-
Greer、South Carolina、アメリカ、29651
- Radiant Research, Greer
-
Mt. Pleasant、South Carolina、アメリカ、29464
- Palmetto Medical Research
-
Myrtle Beach、South Carolina、アメリカ、29572
- Carolina Urologic Research Center
-
-
Tennessee
-
Kingsport、Tennessee、アメリカ、37660
- Holston Medical Group
-
Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
-
-
Texas
-
Corpus Christi、Texas、アメリカ、78414
- Advanced Research Associates
-
Dallas、Texas、アメリカ、75231
- Health Central Women's Care
-
Houston、Texas、アメリカ、77024
- Accelovance
-
Humble、Texas、アメリカ、77338
- Regional Medical Center and Diagnostic
-
San Antonio、Texas、アメリカ、78229
- Urology San Antonio Research, PA
-
San Antonio、Texas、アメリカ、78228
- Radiant Research San Antonio
-
-
Virginia
-
Richmond、Virginia、アメリカ、23235
- Virginia Urology Center
-
Virginia Beach、Virginia、アメリカ、23454
- Urology of Virginia PC
-
-
Washington
-
Seattle、Washington、アメリカ、98105
- Women's Clinical Research Center
-
Seattle、Washington、アメリカ、98166
- Seattle Urology Research Center
-
Seattle、Washington、アメリカ、98166
- Investigational site - Medical Professional
-
-
-
-
British Columbia
-
Kelowna、British Columbia、カナダ、V1Y-2H4
- Southern Interior Medical Center
-
Victoria、British Columbia、カナダ、V8T 5G1
- Can-Med Clinical Research Inc.
-
Victoria、British Columbia、カナダ、V8V 3N1
- Investigational site - Clinical Research
-
-
New Brunswick
-
Fredericton、New Brunswick、カナダ、E3B 5B8
- Investigational site - Professional Corporation
-
-
Ontario
-
Barrie、Ontario、カナダ、L4M 7G1
- The Male/Female Health and Reserach
-
Brantford、Ontario、カナダ、N3R 4N3
- Brantford Urology Research
-
Guelph、Ontario、カナダ、N1H 5J1
- Guelph Urology Associates
-
North Bay、Ontario、カナダ、P1B 4Z2
- Investigational Site
-
Oakville、Ontario、カナダ、L6H 3P1
- The Fe/Male Health Centres
-
Toronto、Ontario、カナダ、M4N 3M5
- SunnyBrook Health Sciences Centre
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria
- Written informed consent prior to the performance of any study-related activity.
- 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:
- 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
Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months
Females:
- Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
- Use of pessary for pelvic prolapse.
Unexplained pelvic mass.
Males and Females:
- 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.
- Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
- Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
- History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
- Suspicion or evidence of cardiac failure.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) >=60 mL/min.
- 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.
- Hyponatremia. Serum sodium level must be within normal limits
- Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
- Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
- Psychogenic or habitual polydipsia
Obstructive sleep apnea
Other
- Known alcohol or substance abuse
- Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
- Previous desmopressin treatment for nocturia.
- 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.
- 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.
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：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).
|
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
|
|
実験的：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).
|
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
他の名前：
|
|
実験的：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).
|
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
他の名前：
|
|
実験的：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).
|
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
他の名前：
|
|
実験的：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).
|
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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
時間枠：- 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
時間枠：- 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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：- 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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Juul KV, Klein BM, Norgaard JP. Long-term durability of the response to desmopressin in female and male nocturia patients. Neurourol Urodyn. 2013 Apr;32(4):363-70. doi: 10.1002/nau.22306. Epub 2012 Sep 12.
- Weiss JP, Zinner NR, Klein BM, Norgaard JP. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012 Apr;31(4):441-7. doi: 10.1002/nau.22243. Epub 2012 Mar 22.
- Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.
- Bliwise DL, Holm-Larsen T, Goble S. Increases in duration of first uninterrupted sleep period are associated with improvements in PSQI-measured sleep quality. Sleep Med. 2014 Oct;15(10):1276-8. doi: 10.1016/j.sleep.2014.05.013. Epub 2014 Jun 13.
- Juul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年5月1日
一次修了 (実際)
2008年2月1日
研究の完了 (実際)
2008年2月1日
試験登録日
最初に提出
2007年5月22日
QC基準を満たした最初の提出物
2007年5月22日
最初の投稿 (見積もり)
2007年5月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月1日
QC基準を満たした最後の更新が送信されました
2015年9月29日
最終確認日
2015年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Placeboの臨床試験
-
Palacky University完了
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
-
Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
-
University Hospital, Strasbourg, France積極的、募集していない