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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nocturia

Intervention: desmopressin acetate (Drug); Placebo (Drug); desmopressin acetate (Drug); desmopressin acetate (Drug); desmopressin acetate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Summary

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.

Clinical Details

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Change from baseline in mean number of nocturnal voids

Proportion of subjects with greater than 33 percent reduction from baseline in mean number of nocturnal voids

Durability of effect in mean number of nocturnal voids

Secondary outcome:

Change from baseline in total sleep time

Change from baseline in initial period of undisturbed sleep

Change from baseline in Quality of Life

Change from baseline in quality of sleep

Treatment safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Written informed consent prior to the performance of any study-related activity. 2. Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day voiding diary Exclusion Criteria: Males: 1. 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 2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months Females: 3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception. 4. Use of pessary for pelvic prolapse 5. Unexplained pelvic mass Males and Females: 6. Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, post void bladder ultrasound or catheterization should be performed to confirm the diagnosis 7. Current or past urologic malignancy (e. g. bladder cancer, prostate cancer, etc.) 8. Clinical evidence of current genito-urinary tract pathology (e. g. infection, stone, tumor, etc.) 9. Neurogenic detrusor activity (previously known as detrusor hyperreflexia) 10. Suspicion or evidence of cardiac failure 11. Uncontrolled hypertension 12. Uncontrolled diabetes mellitus 13. Renal insufficiency. Serum creatinine must be within normal limits. 14. 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. 15. Hyponatremia. Serum sodium level must be within normal limits 16. Syndrome of Inappropriate antidiuretic hormone secretion (SIADH) secretion 17. Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3 day voiding diary 18. Psychogenic or habitual polydipsia 19. Obstructive sleep apnea 20. Hyperkinetic limb disorders (e. g. restless leg syndrome) known to impair sleep Other 21. Known alcohol or substance abuse 22. Work or lifestyle potentially interfering with regular night-time sleep (e. g. shift workers) 23. Previous desmopressin treatment for nocturia 24. Psychiatric condition, mental incapacity or language barrier which, in the judgment of the investigator, would impair patient participation in the trial Concomitant Medications The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i. e. treatment has not been initiated or discontinued and there has been no change in dose):

- Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin);

Uroxatral (alfuzosin)

- 5 alpha-reductase inhibitors: Avodart (dutaseride); Proscar (finasteride)

- Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder:

Detrol, Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)

- Sedative/hypnotic medications for sleep disorders

- Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa

(citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)

- Chronic use of non-steroidal anti-inflammatory agents

- Diabinese (chlorpropamide)

- Carbamazepine (carbatrol/tegretol)

- Amiodarone

The following medications are excluded:

- Diuretics

- Any other investigational drug within 30 days of screening

Locations and Contacts

Radiant Research, Birmingham, Alabama 35209, United States

Radiant Research, Scottsdale, Arizona 85251, United States

Arkansas Primary Care Clinic, Little Rock, Arkansas 72204, United States

Southern Interior Medical Center, Kelowna, British Columbia V1Y-2H4, Canada

Can-Med Clinical Research Inc., Victoria, British Columbia V8T 5G1, Canada

Investigational site - Clinical Research, Victoria, British Columbia V8V 3N1, Canada

Advanced Urology Medical Center, Anaheim, California 92801, United States

Impact Clinical Trials, Beverly Hills, California 90211, United States

Atlantic Urology Medical Group, Long Beach, California 90806, United States

California Professional Research, Newport Beach, California 92660, United States

San Diego Uro-Research, San Diego, California 92103, United States

Radiant Research, Santa Rosa, California 95404, United States

West Coast Clinical Research, Tarzana, California 91356, United States

Western Clinical Research, Torrance, California 90505, United States

Downtown Women's Health Care, Denver, Colorado 80218, United States

Genitourinary Surgical Consultants, Denver, Colorado 80220, United States

Urology Associates PC, Denver, Colorado 80210, United States

Connecticut Clinical Research Center, LLC, Middlebury, Connecticut 06762, United States

South Florida Medical Research, Aventura, Florida 33180, United States

Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States

Medsearch Professional Group, Miami, Florida 33145, United States

Sunrise Medical Research, Plantation, Florida 33324, United States

Radiant Research, Stuart, Florida 34996, United States

Southeastern Research Group, Inc., Tallahassee, Florida 32308, United States

Tampa Bay Urology, Tampa, Florida 33607, United States

Radiant Research, West Palm Beach, Florida 33407, United States

Southeastern Medical Research Institute, Columbus, Georgia 31904, United States

Investigational site - PC, Dunwoody, Georgia 30338, United States

Accelovance, Peoria, Illinois 61602, United States

Radiant Research, Kansas City, Overland park, Kansas 66202, United States

Benchmark Research, Metairie, Louisiana 70006, United States

Pierremont Women's Clinic, Shreveport, Louisiana 71111, United States

Regional Urology, LLC, Shreveport, Louisiana 71106, United States

FutureCare Studies, Inc., Springfield, Massachusetts 01103, United States

Radiant Research Inc., St. Louis, Missouri 63141, United States

Women's Clinic of Lincoln, P.C, Lincoln, Nebraska 68510, United States

Investigational site, Las Vegas, Nevada 89109, United States

Investigational site - Professional Corporation, Fredericton, New Brunswick E3B 5B8, Canada

AdvanceMed Research, Lawrenceville, New Jersey 08648, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

Morristown Urology, Morristown, New Jersey 07960, United States

Urology Group of New Mexico, PC, Albuquerque, New Mexico 87109, United States

Upstate Urology, Albany, New York 12206, United States

Investigational site - Adult & Pediatric Urology, Carmel, New York 10512, United States

AccuMed Research Associates, Garden City, New York 11530, United States

University Urology Associates, New York, New York 10016, United States

Ferring Pharmaceutical Inc, Suffern, New York 10901, United States

Northeast Urology Research, Concord, North Carolina 28025, United States

PharmQuest, Greensboro, North Carolina 27401, United States

New Hanover Medical Research, Wilmington, North Carolina 28401, United States

Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States

Radiant Research, Cincinnati, Ohio 45249, United States

Radiant Research - Akron, Mogadore, Ohio 44260, United States

The Male/Female Health and Reserach, Barrie, Ontario L4M 7G1, Canada

Brantford Urology Research, Brantford, Ontario N3R 4N3, Canada

Guelph Urology Associates, Guelph, Ontario N1H 5J1, Canada

Investigational site, North Bay, Ontario P1B 4Z2, Canada

The Fe/Male Health Centres, Oakville, Ontario L6H 3P1, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania 19004, United States

Philadelphia Clinical Research, LLC, Philadelphia, Pennsylvania 19114, United States

Radiant Research, Philadelphia, Pennsylvania 19115, United States

Advanced Clinical Concepts, Reading, Pennsylvania 19611, United States

University Medical Group, Greenville, South Carolina 29605, United States

Radiant Research, Greer, Greer, South Carolina 29651, United States

Palmetto Medical Research, Mt. Pleasant, South Carolina 29464, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

Advanced Research Associates, Corpus Christi, Texas 78414, United States

Health Central Women's Care, Dallas, Texas 75231, United States

Accelovance, Houston, Texas 77024, United States

Regional Medical Center and Diagnostic, Humble, Texas 77338, United States

Radiant Research San Antonio, San Antonio, Texas 78228, United States

Urology San Antonio Research, PA, San Antonio, Texas 78229, United States

Virginia Urology Center, Richmond, Virginia 23235, United States

Urology of Virginia PC, Virginia Beach, Virginia 23454, United States

Investigational site - Medical Professional, Seattle, Washington 98166, United States

Seattle Urology Research Center, Seattle, Washington 98166, United States

Women's Clinical Research Center, Seattle, Washington 98105, United States

Additional Information

Related publications:

Juul KV, Klein BM, Nørgaard JP. Long-term durability of the response to desmopressin in female and male nocturia patients. Neurourol Urodyn. 2013 Apr;32(4):363-70. doi: 10.1002/nau.22306. Epub 2012 Sep 12. Review.

Starting date: May 2007
Last updated: September 20, 2012

Page last updated: August 23, 2015

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