A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial Investigating the Efficacy and Safety of Two Different Dose Levels of Desmopressin for the Treatment of Nocturia in Adult Men

Ferring Pharmaceuticals35 sites in 1 country183 target enrollmentSeptember 2012

ConditionsNocturia

InterventionsB. Desmopressin 50 µg Placebo

DrugsPlacebo A: Desmopressin 25 µg B. Desmopressin 50 µg

Overview

Phase: Phase 2
Intervention: B. Desmopressin 50 µg
Conditions: Nocturia
Sponsor: Ferring Pharmaceuticals
Enrollment: 183
Locations: 35
Primary Endpoint: Change from baseline in mean number of nocturnal voids
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult men during 12 weeks treatment

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has given written consent prior to any trial-related activity is performed
•Male sex, aged 20 years or older
•At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
•Has given agreement about contraception during the trial

Exclusion Criteria

•Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
•A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
•Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as \>6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
•Chronic prostatitis/chronic pelvic pain syndrome
•Psychogenic or habitual polydipsia
•Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
•A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years
•Genito-urinary tract pathology
•Neurogenic detrusor activity
•Suspicion or evidence of heart failure

Arms & Interventions

B. Desmopressin 50 µg

1 orally disintegrating tablet every night during study period

Intervention: B. Desmopressin 50 µg

C. Placebo

1 orally disintegrating tablet every night during study period

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in mean number of nocturnal voids

Time Frame: During 12 weeks

Secondary Outcomes

Change from baseline in mean time to first void(1, 4, 8 and 12 weeks)
Responder status (33% reduction in nocturnal voids)(1, 4, 8 and 12 weeks)
Change from baseline in mean number of nocturnal voids(1, 4, 8 and 12 weeks)
Change from baseline in mean nocturnal urine volume(1, 4, 8 and 12 weeks)
Change from baseline in nocturnal polyuria index(1, 4, 8 and 12 weeks)
Change from baseline in the effect on sleep disturbance(1, 4, 8 and 12 weeks)
Change from baseline in the impact on quality of life(12 weeks)
Adverse events, changes from baseline in serum sodium level, laboratory values(During 12 weeks)