Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

Completed · Phase 3 · Has a placebo group

Conditions studied: Nocturia

In brief

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Key facts

Study ID

NCT00477490

Run by

Ferring Pharmaceuticals

People needed

799

Starts

2007-05-01

Expected to finish

2008-02-01

Last updated by the study team

2015-11-02

Who can join

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

You may qualify if…

• Written informed consent prior to the performance of any study-related activity.
• Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day frequency-volume chart during the screening period.

You may not qualify if…

• Males:
• Clinical suspicion of bladder outlet obstruction and/or urine flow < 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis
• Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months
• Females:
• Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
• Use of pessary for pelvic prolapse.
• Unexplained pelvic mass.
• Males and Females:
• Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
• Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
• Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
• History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
• Suspicion or evidence of cardiac failure.
• Uncontrolled hypertension.
• Uncontrolled diabetes mellitus.
• Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) >=60 mL/min.
• Active hepatic and/or biliary disease. Aspartate transaminase (AST) or alanine transaminase (ALT) should not be >2 times the upper limit of normal. Total bilirubin should not be > 1.5 mg/dL.
• Hyponatremia. Serum sodium level must be within normal limits
• Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
• Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
• Psychogenic or habitual polydipsia
• Obstructive sleep apnea
• Other
• Known alcohol or substance abuse
• Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)

Where it is running

• Radiant Research — Scottsdale, Arizona, United States
• Arkansas Primary Care Clinic — Little Rock, Arkansas, United States
• Advanced Urology Medical Center — Anaheim, California, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• California Professional Research — Newport Beach, California, United States
• San Diego Uro-Research — San Diego, California, United States
• Radiant Research — Santa Rosa, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• Western Clinical Research — Torrance, California, United States
• Urology Associates PC — Denver, Colorado, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Genitourinary Surgical Consultants — Denver, 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
• Medsearch Professional Group — Miami, Florida, United States
• Sunrise Medical Research — Plantation, Florida, United States
• Radiant Research — Stuart, Florida, United States
• Southeastern Research Group, Inc. — Tallahassee, Florida, United States
• Tampa Bay Urology — Tampa, Florida, United States
• Radiant Research — West Palm Beach, Florida, United States
• Southeastern Medical Research Institute — Columbus, Georgia, United States
• Investigational site - PC — Dunwoody, Georgia, United States
• Radiant Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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