Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
NCT ID: NCT00477490
Last Updated: 2015-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
799 participants
INTERVENTIONAL
2007-05-31
2008-02-29
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
TRIPLE
Study Groups
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Placebo
Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
desmopressin melt 10 μg
Participants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
desmopressin melt 25 μg
Participants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
desmopressin melt 50 μg
Participants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
desmopressin melt 100 μg
Participants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Interventions
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desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
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, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
7. Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
8. Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
9. History of 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 and estimated glomerular filtration rate (eGFR) \>=60 mL/min.
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).
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
Other
20. Known alcohol or substance abuse
21. Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
22. Previous desmopressin treatment for nocturia.
23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity or language barrier that, in the judgment of the investigator, could impair patient participation in the trial.
24. Use of loop diuretics (furosemide, torsemide, ethacrynic acid). Other classes of diuretics (thiazides, triamterene, chlorthalidone, amiloride, indapamide) were permitted, either as monotherapy or combination therapy. Subjects using a diuretic were to be encouraged to take it in the morning, if medically feasible.
25. Use of any other investigational drug within 30 days of screening.
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 (dutasteride); 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 nonsteroidal anti-inflammatory agents
* Diabinese (chlorpropamide)
* Carbamazepine (carbatrol/tegretol)
* Amiodarone
18 Years
ALL
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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Radiant Research
Birmingham, Alabama, United States
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
Accelovance
Peoria, Illinois, United States
Radiant Research, Kansas City
Overland Park, Kansas, United States
Benchmark Research
Metairie, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Pierremont Women's Clinic
Shreveport, Louisiana, United States
FutureCare Studies, Inc.
Springfield, Massachusetts, United States
Radiant Research Inc.
St Louis, Missouri, United States
Women's Clinic of Lincoln, P.C
Lincoln, Nebraska, United States
Investigational site
Las Vegas, Nevada, United States
AdvanceMed Research
Lawrenceville, New Jersey, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Morristown Urology
Morristown, New Jersey, United States
Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States
Upstate Urology
Albany, New York, United States
Investigational site - Adult & Pediatric Urology
Carmel, New York, United States
AccuMed Research Associates
Garden City, New York, United States
University Urology Associates
New York, New York, United States
Ferring Pharmaceutical Inc
Suffern, New York, United States
Northeast Urology Research
Concord, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
Radiant Research - Akron
Mogadore, Ohio, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Radiant Research
Philadelphia, Pennsylvania, United States
Advanced Clinical Concepts
Reading, Pennsylvania, United States
University Medical Group
Greenville, South Carolina, United States
Radiant Research, Greer
Greer, South Carolina, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Advanced Research Associates
Corpus Christi, Texas, United States
Health Central Women's Care
Dallas, Texas, United States
Accelovance
Houston, Texas, United States
Regional Medical Center and Diagnostic
Humble, Texas, United States
Radiant Research San Antonio
San Antonio, Texas, United States
Urology San Antonio Research, PA
San Antonio, Texas, United States
Virginia Urology Center
Richmond, Virginia, United States
Urology of Virginia PC
Virginia Beach, Virginia, United States
Women's Clinical Research Center
Seattle, Washington, United States
Investigational site - Medical Professional
Seattle, Washington, United States
Seattle Urology Research Center
Seattle, Washington, United States
Southern Interior Medical Center
Kelowna, British Columbia, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada
Investigational site - Clinical Research
Victoria, British Columbia, Canada
Investigational site - Professional Corporation
Fredericton, New Brunswick, Canada
The Male/Female Health and Reserach
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
Guelph Urology Associates
Guelph, Ontario, Canada
Investigational site
North Bay, Ontario, Canada
The Fe/Male Health Centres
Oakville, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Juul KV, Klein BM, Norgaard 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.
Weiss JP, Zinner NR, Klein BM, Norgaard JP. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012 Apr;31(4):441-7. doi: 10.1002/nau.22243. Epub 2012 Mar 22.
Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.
Bliwise DL, Holm-Larsen T, Goble S. Increases in duration of first uninterrupted sleep period are associated with improvements in PSQI-measured sleep quality. Sleep Med. 2014 Oct;15(10):1276-8. doi: 10.1016/j.sleep.2014.05.013. Epub 2014 Jun 13.
Juul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.
Other Identifiers
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FE992026 CS29
Identifier Type: -
Identifier Source: org_study_id
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