Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
NCT ID: NCT01262456
Last Updated: 2015-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
395 participants
INTERVENTIONAL
2011-02-28
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Desmopressin 50 μg Double-Blind / 100 μg Open-Label
Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Desmopressin
Desmopressin 75 μg Double-Blind / 100 μg Open-Label
Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Desmopressin
Placebo Double-Blind / Desmopressin 100 μg Open-Label
Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Desmopressin
Placebo
Interventions
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Desmopressin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Radiant Research, Inc.
Scottsdale, Arizona, United States
Premiere Pharmaceutical Research
Tempe, Arizona, United States
Family Medical Center
Foothill Rance, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Radiant Research, Inc.
Denver, Colorado, United States
Front Range Clinical Research, LLC
Wheat Ridge, Colorado, United States
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Pinellas Urology, Inc
St. Petersburg, Florida, United States
Midtown Medical Center
Tampa, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
Southeastern Medical Research Institute
Columbus, Georgia, United States
Radiant Research, Inc.
Chicago, Illinois, United States
Accelovance
Peoria, Illinois, United States
Accelovance
South Bend, Indiana, United States
FutureCare Studies, Inc.
Springfield, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beyer Research
Kalmazoo, Michigan, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Radiant Research
Las Vegas, Nevada, United States
Anderson & Collins Clinical Research Inc.
Edison, New Jersey, United States
Urology Center Research Institute
Englewood, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
University Urology Associates
New York, New York, United States
Radiant Research, Inc.
Akron, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Complete HealthCare
Columbus, Ohio, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
Penn Urology
Philadelphia, Pennsylvania, United States
Hartwell Research Group, LLC
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Radiant Research Inc.
Dallas, Texas, United States
Quality Research Incorporated
San Antonio, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Wilford Hall Medical Center
San Antonio, Texas, United States
Exemplar Research Inc.
Morgantown, West Virginia, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
The Male/ Female Health and Research Centre
Barrie, Ontario, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada
Investigational Site
North Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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FE992026 CS41
Identifier Type: -
Identifier Source: org_study_id
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