An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615836
First received: January 18, 2008
Last updated: October 13, 2010
Last verified: October 2010
  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: lyophilisate oral of desmopressin
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 Multi-Center Extension Study Investigating the Long Term 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 in mean number of nocturnal voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with > 33% reduction from baseline in mean number of voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total sleep time [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • Safety of the "Melt" formulation [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minirin® Melt 10ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
10ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 25ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
25ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 50ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
50ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt
Active Comparator: Minirin® Melt 100ug
desmopressin acetate (Minirin® Melt)
Drug: lyophilisate oral of desmopressin
100ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
Other Name: Minirin® Melt

Detailed Description:

The objective of the present study is to investigate the long-term efficacy and safety of the melt formulation of desmopressin.

  Eligibility

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

Inclusion Criteria:

  • Written informed consent prior to the performance of any study-related activity.
  • Currently enrolled in Protocol. FE992026 CS29, entitled "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" and have completed at least Visit 3E in Part 11. Note: All subjects must be randomized into Part I1 of Protocol CS29 and have completed at least Visit 3E (Day 15) prior to rollover into this study. A subject can be enrolled into this study on the same day they complete Visit 3E.

Exclusion Criteria:

(Note: All changes are measured relative to the baseline values established in Protocol CS29)

  • Change in mean number of nocturnal voids
  • Proportion of subjects with > 33% reduction in the mean number of nocturnal voids
  • Change in the duration of the first sleep period
  • Change in duration of total sleep time
  • Change in nocturia-specific quality of life as assessed by scores on the International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) and the Nocturia Quality of Life Questionnaire (NQoL)
  • Change in quality of sleep as assessed by the global score of the Pittsburgh Sleep Quality Index (PSQI)
  • Change in overall Quality of Life as assessed by the SF-12
  • Treatment safety
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615836

  Hide Study Locations
Locations
United States, Arizona
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Arkansas Primary Care Clinic, PA
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
California Professional Research
Newport Beach, California, United States, 92660
San Diego Uro-Reseach
San Diego, California, United States, 92103
Radiant Research
Santa Rosa, California, United States, 95405
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 Health Research Group, LLC
Clearwater, Florida, United States, 33759
Radiant Research - St. Petersburg
Pinellas Park, Florida, United States, 33781
Sunrise Medical Research
Plantation, Florida, United States, 33324
Radiant Research
Stuart, Florida, United States, 34996
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
Dunwoody, Georgia, United States, 30338
United States, Illinois
Radiant Research, Inc
Chicago, Illinois, United States, 60654
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
United States, Massachusetts
FutureCare Studies, Inc.
Springfield, Massachusetts, United States, 01103
United States, Minnesota
Radiant Research, Minneapolis
Edina, Minnesota, United States, 55435
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
Sheldon J Freedman Ltd
Las Vegas, Nevada, United States
United States, New Jersey
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States, 07202
Lawrenceville Urology, P.A. DBA
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States, 87109
United States, New York
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
Upstate Urology
NY, New York, United States, 12206-1092
Hudson Valley Urology, PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27408
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 Inc.
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
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States, 19114
Advanced Clinical Concepts
West Readings, Pennsylvania, United States, 19611
United States, South Carolina
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
United States, Texas
Advanced Research Associates
Corpus Christi, Texas, United States, 78414
Accelovance
Houston, Texas, United States, 77024
Investigational site - NationsMed Clinical Research
Houston, Texas, United States, 77004
Regional Medical Center and Diagnostic
Humble, Texas, United States, 77338
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
IMED Research, P.A.
San Antonio, Texas, United States, 78258
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
NationsMed
Stafford, Texas, United States
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia PC
Virginia Beach, Virginia, United States, 23454
United States, Washington
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 Research Inc.
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 Research
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 7K8
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00615836     History of Changes
Other Study ID Numbers: FE992026 CS31
Study First Received: January 18, 2008
Last Updated: October 13, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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 17, 2014