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

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nocturia

Intervention: lyophilisate oral of desmopressin (Drug); lyophilisate oral of desmopressin (Drug); lyophilisate oral of desmopressin (Drug); lyophilisate oral of desmopressin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals


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.

Clinical Details

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

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

Primary outcome:

Change in mean number of nocturnal voids

Proportion of subjects with > 33% reduction from baseline in mean number of voids

Secondary outcome:

Change in total sleep time

Quality of life

Safety of the "Melt" formulation

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Radiant Research, Scottsdale, Arizona 85251, United States

Arkansas Primary Care Clinic, PA, Little Rock, Arkansas 72204, United States

Southern Interior Medical Research Inc., Kelowna, British Columbia V1Y-2H4, Canada

Can-Med Clinical Research Inc., Victoria, British Columbia V8T 5G1, Canada

Investigational site - Clinical Research, Victoria, British Columbia V8V 3N1, Canada

Advanced Urology Medical Center, Anaheim, California 92801, United States

Impact Clinical Trials, Beverly Hills, California 90211, United States

California Professional Research, Newport Beach, California 92660, United States

San Diego Uro-Reseach, San Diego, California 92103, United States

Radiant Research, Santa Rosa, California 95405, United States

West Coast Clinical Research, Tarzana, California 91356, United States

Western Clinical Research, Torrance, California 90505, United States

Downtown Women's Health Care, Denver, Colorado 80218, United States

Genitourinary Surgical Consultants, Denver, Colorado 80220, United States

Urology Associates PC, Denver, Colorado 80210, United States

Connecticut Clinical Research Center, LLC, Middlebury, Connecticut 06762, United States

South Florida Medical Research, Aventura, Florida 33180, United States

Women's Health Research Group, LLC, Clearwater, Florida 33759, United States

Radiant Research - St. Petersburg, Pinellas Park, Florida 33781, United States

Sunrise Medical Research, Plantation, Florida 33324, United States

Radiant Research, Stuart, Florida 34996, United States

Tampa Bay Urology, Tampa, Florida 33607, United States

Radiant Research, West Palm Beach, Florida 33407, United States

Southeastern Medical Research Institute, Columbus, Georgia 31904, United States

Investigational site, Dunwoody, Georgia 30338, United States

Radiant Research, Inc, Chicago, Illinois 60654, United States

Accelovance, Peoria, Illinois 61602, United States

Radiant Research, Kansas City, Overland Park, Kansas 66202, United States

Benchmark Research, Metairie, Louisiana 70006, United States

Regional Urology, LLC, Shreveport, Louisiana 71106, United States

FutureCare Studies, Inc., Springfield, Massachusetts 01103, United States

Radiant Research, Minneapolis, Edina, Minnesota 55435, United States

Radiant Research, Inc., St. Louis, Missouri 63141, United States

Women's Clinic of Lincoln, P.C., Lincoln, Nebraska 68510, United States

Sheldon J Freedman Ltd, Las Vegas, Nevada, United States

Investigational site - Professional Corporation, Fredericton, New Brunswick E3B 5B8, Canada

Central Jersey Medical Research Center, Elizabeth, New Jersey 07202, United States

Lawrenceville Urology, P.A. DBA, Lawrenceville, New Jersey 08648, United States

Urology Group of New Mexico, PC, Albuquerque, New Mexico 87109, United States

Investigational site - Adult & Pediatric Urology, Carmel, New York 10512, United States

AccuMed Research Associates, Garden City, New York 11530, United States

University Urology Associates, New York, New York 10016, United States

Upstate Urology, NY, New York 12206-1092, United States

Hudson Valley Urology, PC, Poughkeepsie, New York 12601, United States

PharmQuest, Greensboro, North Carolina 27408, United States

New Hanover Medical Research, Wilmington, North Carolina 28401, United States

Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States

Radiant Research Inc., Cincinnati, Ohio 45249, United States

Radiant Research - Akron, Mogadore, Ohio 44260, United States

The Male/Female Health and Research, Barrie, Ontario L4M 7G1, Canada

Brantford Urology Research, Brantford, Ontario N3R 4N3, Canada

Guelph Urology Associates, Guelph, Ontario N1H 5J1, Canada

Investigational site, North Bay, Ontario P1B 7K8, Canada

The Fe/Male Health Centres, Oakville, Ontario L6H 3P1, Canada

Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania 19004, United States

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19114, United States

Advanced Clinical Concepts, West Readings, Pennsylvania 19611, United States

Radiant Research, Greer, Greer, South Carolina 29651, United States

Palmetto Medical Research, Mt. Pleasant, South Carolina 29464, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Advanced Research Associates, Corpus Christi, Texas 78414, United States

Accelovance, Houston, Texas 77024, United States

Investigational site - NationsMed Clinical Research, Houston, Texas 77004, United States

Regional Medical Center and Diagnostic, Humble, Texas 77338, United States

IMED Research, P.A., San Antonio, Texas 78258, United States

Innovative Clinical Trials, San Antonio, Texas 78229, United States

Radiant Research San Antonio, San Antonio, Texas 78229, United States

NationsMed, Stafford, Texas, United States

Virginia Urology, Richmond, Virginia 23235, United States

Urology of Virginia PC, Virginia Beach, Virginia 23454, United States

Seattle Urology Research Center, Seattle, Washington 98166, United States

Women's Clinical Research Center, Seattle, Washington 98105, United States

Additional Information

Starting date: December 2007
Last updated: October 13, 2010

Page last updated: August 23, 2015

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