Clinical trial NCT00615836: An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: FE992026 CS31 was a multicenter open-label extension study for patients who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II of that study.

The CS29 study was structured into 2 double-blind parts (Part I and Part II). In Part I, the initial 28-day treatment period, participants were randomly assigned to 1 of 5 treatment groups: placebo or desmopressin Melt 10 μg, 25 μg, 50 μg, or 100 μg. Immediately upon completion of Part I of the study, all participants on active treatment continued into Part II on the same treatment for approximately 1 to 6 months. Participants assigned to placebo in Part I were randomly assigned to 1 of the 4 active treatments in Part II, based on re-randomization predetermined at the initial randomization (to maintain the blind). Part II began at the final visit for Part I and continued until the database for Part I was locked. Therefore, treatment duration for Part II varied between 1 and 6 months, depending upon when the participant entered.

Upon completion of Part II of CS29, participants were given the option to participate in the open-label extension study (CS31). During CS31, each participant assigned to the 10 μg dose was switched to a higher dose in an open-label manner among the remaining 3 higher doses.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline in Mean Number of Nocturnal Voids
timeFrame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
measure: Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
timeFrame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
measure: Change From Baseline in Initial Period of Undisturbed Sleep
timeFrame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Secondary outcomes:
measure: Change From Baseline in Total Sleep Time
timeFrame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
measure: Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
timeFrame: 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)
measure: Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
timeFrame: 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)
measure: Change From Baseline in NQoL Bother/Concern Domain Score
timeFrame: 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)
measure: Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
timeFrame: 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)
measure: Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
timeFrame: 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)
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
timeFrame: 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)
measure: Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
timeFrame: 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)
measure: Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
timeFrame: 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)
measure: Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: San Diego
country: United States
facility: San Diego Uro-Reseach
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Denver
country: United States
facility: Urology Associates PC
state: Colorado
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center, LLC
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Health Research Group, LLC
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research - St. Petersburg
state: Florida
city: Plantation
country: United States
facility: Sunrise Medical Research
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Urology
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research
state: Florida
city: Columbus
country: United States
facility: Southeastern Medical Research Institute
state: Georgia
city: Dunwoody
country: United States
facility: Investigational site
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc
state: Illinois
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: Overland Park
country: United States
facility: Radiant Research, Kansas City
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Springfield
country: United States
facility: FutureCare Studies, Inc.
state: Massachusetts
city: Edina
country: United States
facility: Radiant Research, Minneapolis
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon J Freedman Ltd
state: Nevada
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrenceville Urology, P.A. DBA
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico, PC
state: New Mexico
city: Carmel
country: United States
facility: Investigational site - Adult & Pediatric Urology
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: NY
country: United States
facility: Upstate Urology
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research Inc.
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research - Akron
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research, LLC
state: Pennsylvania
city: West Readings
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research, Greer
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Investigational site - NationsMed Clinical Research
state: Texas
city: Houston
country: United States
facility: Accelovance
state: Texas
city: Humble
country: United States
facility: Regional Medical Center and Diagnostic
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: San Antonio
country: United States
facility: IMED Research, P.A.
state: Texas
city: Stafford
country: United States
facility: NationsMed
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia PC
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Investigational site - Clinical Research
state: British Columbia
city: Fredericton
country: Canada
facility: Investigational site - Professional Corporation
state: New Brunswick
city: Barrie
country: Canada
facility: The Male/Female Health and Research
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Urology Associates
state: Ontario
city: North Bay
country: Canada
facility: Investigational site
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.