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

NCT00615836 | Completed Phase 3 Results DMC

• 1 other identifier: FE992026 CS31
• Study Type: interventional
• Target: 554
• Locations: 2 countries
• Sites: 73

Brief Summary

The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.

Conditions

Nocturia

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Mean Number of Nocturnal Voids

  Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.

  Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

• Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids

  Percentage of participants with \>33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit. Participants in the 10μg arm are included only until the time of dose escalation.

  Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

• Change From Baseline in Initial Period of Undisturbed Sleep

  Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.

  Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

Secondary Outcomes (10)

• Change From Baseline in Total Sleep Time

  Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.

• Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score

  Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

• Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score

  Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

• Change From Baseline in NQoL Bother/Concern Domain Score

  Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

• Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score

  Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)

Study Arms (4)

Desmopressin Melt 10 μg

EXPERIMENTAL

Participants received desmopressin melt 10 μg once a day, placed under the tongue one hour before bedtime until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).

Drug: Desmopressin Melt

Desmopressin Melt 25 μg

EXPERIMENTAL

Participants received desmopressin melt 25 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

Drug: Desmopressin Melt

Desmopressin Melt 50 μg

EXPERIMENTAL

Participants received desmopressin melt 50 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

Drug: Desmopressin Melt

Desmopressin Melt 100 μg

EXPERIMENTAL

Participants received desmopressin melt 100 μg once a day, placed under the tongue one hour before bedtime for up to 2 years and 2.5 months.

Drug: Desmopressin Melt

Interventions

Desmopressin Melt DRUG

An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.

Also known as: Minirin® Melt, Nocturin®, FE992026

Desmopressin Melt 10 μg; Desmopressin Melt 100 μg; Desmopressin Melt 25 μg; Desmopressin Melt 50 μg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to the performance of any study-related activity.
• Was randomized into Part II of Protocol FE992026 CS29 (NCT00477490), 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 II (Day 15).

You may not qualify if:

• Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (73)

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204, United States

Location

Advanced Urology Medical Center

Anaheim, California, 92801, United States

Location

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

California Professional Research

Newport Beach, California, 92660, United States

Location

San Diego Uro-Reseach

San Diego, California, 92103, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

Western Clinical Research

Torrance, California, 90505, United States

Location

Urology Associates PC

Denver, Colorado, 80210, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80218, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

Connecticut Clinical Research Center, LLC

Middlebury, Connecticut, 06762, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Women's Health Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Radiant Research - St. Petersburg

Pinellas Park, Florida, 33781, United States

Location

Sunrise Medical Research

Plantation, Florida, 33324, United States

Location

Radiant Research

Stuart, Florida, 34996, United States

Location

Tampa Bay Urology

Tampa, Florida, 33607, United States

Location

Radiant Research

West Palm Beach, Florida, 33407, United States

Location

Southeastern Medical Research Institute

Columbus, Georgia, 31904, United States

Location

Investigational site

Dunwoody, Georgia, 30338, United States

Location

Radiant Research, Inc

Chicago, Illinois, 60654, United States

Location

Accelovance

Peoria, Illinois, 61602, United States

Location

Radiant Research, Kansas City

Overland Park, Kansas, 66202, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

FutureCare Studies, Inc.

Springfield, Massachusetts, 01103, United States

Location

Radiant Research, Minneapolis

Edina, Minnesota, 55435, United States

Location

Radiant Research, Inc.

St Louis, Missouri, 63141, United States

Location

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, 68510, United States

Location

Sheldon J Freedman Ltd

Las Vegas, Nevada, United States

Location

Central Jersey Medical Research Center

Elizabeth, New Jersey, 07202, United States

Location

Lawrenceville Urology, P.A. DBA

Lawrenceville, New Jersey, 08648, United States

Location

Urology Group of New Mexico, PC

Albuquerque, New Mexico, 87109, United States

Location

Investigational site - Adult & Pediatric Urology

Carmel, New York, 10512, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Upstate Urology

New York, New York, 12206-1092, United States

Location

Hudson Valley Urology, PC

Poughkeepsie, New York, 12601, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

New Hanover Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research Inc.

Cincinnati, Ohio, 45249, United States

Location

Radiant Research - Akron

Mogadore, Ohio, 44260, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Philadelphia Clinical Research, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Advanced Clinical Concepts

West Readings, Pennsylvania, 19611, United States

Location

Radiant Research, Greer

Greer, South Carolina, 29651, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Investigational site - NationsMed Clinical Research

Houston, Texas, 77004, United States

Location

Accelovance

Houston, Texas, 77024, United States

Location

Regional Medical Center and Diagnostic

Humble, Texas, 77338, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

IMED Research, P.A.

San Antonio, Texas, 78258, United States

Location

NationsMed

Stafford, Texas, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Urology of Virginia PC

Virginia Beach, Virginia, 23454, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Seattle Urology Research Center

Seattle, Washington, 98166, United States

Location

Southern Interior Medical Research Inc.

Kelowna, British Columbia, V1Y-2H4, Canada

Location

Can-Med Clinical Research Inc.

Victoria, British Columbia, V8T 5G1, Canada

Location

Investigational site - Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

Investigational site - Professional Corporation

Fredericton, New Brunswick, E3B 5B8, Canada

Location

The Male/Female Health and Research

Barrie, Ontario, L4M 7G1, Canada

Location

Brantford Urology Research

Brantford, Ontario, N3R 4N3, Canada

Location

Guelph Urology Associates

Guelph, Ontario, N1H 5J1, Canada

Location

Investigational site

North Bay, Ontario, P1B 7K8, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

Related Publications (1)

• 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.

  PMID: 21367921 DERIVED

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: February 14, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11

Locations

US (64); CA (9)