Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Nocturia

In brief

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 in adult females with nocturia.

Key facts

Study ID

NCT01223937

Run by

Ferring Pharmaceuticals

People needed

268

Starts

2010-11-01

Expected to finish

2011-11-01

Last updated by the study team

2015-10-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Affiliated Research Center Inc. — Huntsville, Alabama, United States
• Radiant Research Inc. — Scottsdale, Arkansas, United States
• Family Medical Center — Foothill Ranch, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Radiant Research Inc. — Santa Rosa, California, United States
• Downtown Woman's Health Care — Denver, Colorado, United States
• Front Range Clinical Research — Wheat Ridge, Colorado, 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
• DMI Research — Pinellas Park, Florida, United States
• Southeastern Institute — Columbus, Georgia, United States
• Southeastern Medical Research Institute — Columbus, Georgia, United States
• Radiant Research Inc. — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Accelovance — Peoria, Illinois, United States
• Accelovance — South Bend, Indiana, United States
• FutureCare Studies — Springfield, Massachusetts, United States
• Bay State Clinical Trials, Inc. — Watertown, Massachusetts, United States
• Beyer Research — Paw Paw, Michigan, United States
• Remedica, LLC — Rochester, Michigan, United States
• Radiant Research, Inc. — Edina, Minnesota, United States
• Radiant Research, Inc. — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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