Status:
COMPLETED
Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Nocturia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment ...
Eligibility Criteria
Inclusion
- Written informed consent prior to performance of any trial-related activity
- Female sex 18 years of age or older
- At least 2 voids every night in a consecutive 3-day period during the screening period
Exclusion
- 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
- Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
- Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
- Central or nephrogenic diabetes insipidus
- Syndrome of inappropriate anti-diuretic hormone secretion
- Current or a history of urologic malignancies e.g. bladder 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 e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
- Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months' duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT01223937
Start Date
November 1 2010
End Date
November 1 2011
Last Update
October 15 2015
Active Locations (45)
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1
Medical Affiliated Research Center Inc.
Huntsville, Alabama, United States
2
Radiant Research Inc.
Scottsdale, Arkansas, United States
3
Family Medical Center
Foothill Ranch, California, United States
4
Axis Clinical Trials
Los Angeles, California, United States