Clinical trial NCT01223937: Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in adult females with nocturia.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

1. 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)
2. Interstitial cystitis
3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
5. Central or nephrogenic diabetes insipidus
6. Syndrome of inappropriate anti-diuretic hormone secretion
7. Current or a history of urologic malignancies e.g. bladder cancer
8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms
9. Neurogenic detrusor activity (detrusor overactivity).
10. Suspicion or evidence of cardiac failure
11. Uncontrolled hypertension
12. Uncontrolled diabetes mellitus
13. Hyponatraemia: Serum sodium level must be within normal limits
14. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
15. 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
16. History of obstructive sleep apnea
17. Previous desmopressin treatment for nocturia
18. Treatment with another investigational product within 3 months prior to screening
19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
20. 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
21. Known alcohol or substance abuse
22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers
23. 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

Primary outcomes:
measure: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
timeFrame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
measure: Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
timeFrame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
Secondary outcomes:
measure: Change From Baseline in Mean Number of Nocturnal Voids at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in Mean Time to First Nocturnal Void at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in Nocturnal Urine Volume at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Change From Baseline in 24-Hour Urine Volume at Month 3
timeFrame: Day 1 (Baseline), Month 3
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 3 months
measure: Minimum Post-Treatment Serum Sodium Levels
timeFrame: Day 1 up to 3 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center Inc.
state: Alabama
city: Scottsdale
country: United States
facility: Radiant Research Inc.
state: Arkansas
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Santa Rosa
country: United States
facility: Radiant Research Inc.
state: California
city: Denver
country: United States
facility: Downtown Woman's Health Care
state: Colorado
city: Wheatridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Columbus
country: United States
facility: Southeastern Institute
state: Georgia
city: Columbus
country: United States
facility: Southeastern Medical Research Institute
state: Georgia
city: Chicago
country: United States
facility: Radiant Research Inc.
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: South Bend
country: United States
facility: Accelovance
state: Indiana
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Paw Paw
country: United States
facility: Beyer Research
state: Michigan
city: Rochester
country: United States
facility: Remedica, LLC
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Radiant Research
state: Nevada
city: Edison
country: United States
facility: Anderson & Collins Clinical Research Inc
state: New Jersey
city: Garden City
country: United States
facility: ACCUMED Research Associates
state: New York
city: Williamsville
country: United States
facility: Center for Urologic Research of WNY, LLC
state: New York
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbus
country: United States
facility: Complete HealthCare for Women
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research, LLC
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Morgantown
country: United States
facility: Exemplar Research Inc.
state: West Virginia
city: Victoria
country: Canada
facility: CanMed Clinical Research Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male/Female Health Research Center
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates/Urologic Medical Research
state: Ontario
city: North Bay
country: Canada
facility: Investigational site
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Sand PK, Dmochowski RR, Reddy J, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):958-64. doi: 10.1016/j.juro.2013.02.037. Epub 2013 Feb 20.
citation: 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.