Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00477490
First received: May 22, 2007
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Nocturia
Drug: desmopressin acetate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean number of nocturnal voids [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with greater than 33 percent reduction from baseline in mean number of nocturnal voids [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Durability of effect in mean number of nocturnal voids [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total sleep time [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in initial period of undisturbed sleep [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in quality of sleep [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Treatment safety [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]

Enrollment: 754
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will take a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients will be randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: Placebo
Oral placebo placed under the participants tongue, without water, once daily about one hour before bedtime.
Experimental: desmopressin melt 10 μg
Participants will take desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
10 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt
Experimental: desmopressin melt 25 μg
Participants will take desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
25 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt
Experimental: desmopressin melt 50 μg
Participants will take desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
50 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: 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 study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
100 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 voiding diary

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, post void bladder ultrasound or catheterization should be performed to confirm the diagnosis
  7. Current or past urologic malignancy (e.g. bladder cancer, prostate cancer, etc.)
  8. Clinical evidence of current genito-urinary tract pathology (e.g. infection, stone, tumor, etc.)
  9. 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.
  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) secretion
  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
  20. Hyperkinetic limb disorders (e.g. restless leg syndrome) known to impair sleep Other
  21. Known alcohol or substance abuse
  22. Work or lifestyle potentially interfering with regular night-time sleep (e.g. shift workers)
  23. Previous desmopressin treatment for nocturia
  24. Psychiatric condition, mental incapacity or language barrier which, in the judgment of the investigator, would impair patient participation in the trial

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 (dutaseride); 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 non-steroidal anti-inflammatory agents
  • Diabinese (chlorpropamide)
  • Carbamazepine (carbatrol/tegretol)
  • Amiodarone

The following medications are excluded:

  • Diuretics
  • Any other investigational drug within 30 days of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477490

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00477490     History of Changes
Other Study ID Numbers: FE992026 CS29, ICH GCD
Study First Received: May 22, 2007
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Canadian Health Authority

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014