Clinical trial NCT01262456: Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 395
Sex: MALE
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 trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent prior to performance of any trial-related activity
* Male sex 18 years of age or older
* At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.

Exclusion Criteria:

* Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
* Interstitial Cystitis
* Chronic prostatitis/chronic pelvic pain syndrome
* Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
* Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
* Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
* Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
* Central or nephrogenic diabetes insipidus.
* Syndrome of inappropriate anti-diuretic hormone.
* Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
* Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
* Neurogenic detrusor activity (detrusor overactivity)
* Suspicion or evidence of cardiac failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Hyponatraemia: Serum sodium level must be within normal limits
* Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
* Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
* History of obstructive sleep apnea
* Previous desmopressin treatment for nocturia
* Treatment with another investigational product within 3 months prior to screening
* Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
* Known alcohol or substance abuse
* Work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers
* Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial

Primary outcomes:
measure: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
timeFrame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
measure: Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
timeFrame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Secondary outcomes:
measure: Change From Baseline in Mean Number of Nocturnal Voids at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in Mean Time to First Nocturnal Void at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in Nocturnal Urine Volume at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in 24-Hour Urine Volume at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
timeFrame: From Day 1 through Month 3 (double-blind period)
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
timeFrame: Month 1 of open-label period (Month 4 of treatment)
measure: Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
timeFrame: Day 1 through Month 3 (double-blind period)
measure: Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
timeFrame: Month 1 of open-label period (Month 4 of treatment)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research
state: Arizona
city: Foothill Rance
country: United States
facility: Family Medical Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Wheat Ridge
country: United States
facility: Front Range Clinical Research, LLC
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 Medical Research Group, LLC
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: St. Petersburg
country: United States
facility: Pinellas Urology, Inc
state: Florida
city: Tampa
country: United States
facility: Midtown Medical Center
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Columbus
country: United States
facility: Southeastern Medical Research Institute
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: South Bend
country: United States
facility: Accelovance
state: Indiana
city: Springfield
country: United States
facility: FutureCare Studies, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Kalmazoo
country: United States
facility: Beyer Research
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Radiant Research
state: Nevada
city: Edison
country: United States
facility: Anderson & Collins Clinical Research Inc.
state: New Jersey
city: Englewood
country: United States
facility: Urology Center Research Institute
state: New Jersey
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: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbus
country: United States
facility: Complete HealthCare
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Urology
state: Pennsylvania
city: Anderson
country: United States
facility: Hartwell Research Group, LLC
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Quality Research Incorporated
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Morgantown
country: United States
facility: Exemplar Research Inc.
state: West Virginia
city: Victoria
country: Canada
facility: Can-Med Clinical Research, Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male/ Female Health and Research Centre
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates / Urologic Medical Research
state: Ontario
city: North Bay
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.