Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men (NOC)

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

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

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Placebo; Drug: A: Desmopressin 25 µg; Drug: B. Desmopressin 50 µg

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • Clinic Tsudanuma
  • Fukui, Japan
    • University of Fukui Hospital
  • Gunma, Japan
    • Kato Clinic
  • Gunma, Japan
    • Umeyama Clinic
  • Hyogo, Japan
    • Harada Urology Clinic
  • Hyogo, Japan
    • Sakaguchi Urological Clinic
  • Kanagawa, Japan
    • Nakamura Urology Clinic
  • Kanagawa, Japan
    • Nishi-Yokohama International Hospital
  • Kanagawa, Japan
    • Yokohama Shinmidori General Hospital
  • Kochi, Japan
    • Izumino Hospital, Bouchikai
  • Kochi, Japan
    • Kamei Clinic
  • Osaka, Japan
    • Den Urology Clinic
  • Osaka, Japan
    • Iwasa Clinic
  • Osaka, Japan
    • Kanno Clinic
  • Osaka, Japan
    • Morimoto Clinic
  • Osaka, Japan
    • Naka Clinic
  • Osaka, Japan
    • Uemura Clinic
  • Osaka, Japan
    • Urology department Kuroda Clinic
  • Osaka, Japan
    • Yamaguchi Clinic
  • Osaka, Japan
    • Yamanaka Clinic
  • Saitama, Japan
    • Fukuda Clinic
  • Saitama, Japan
    • Yasuda Urology Clinic
  • Tokyo, Japan
    • Hirano Clinic
  • Tokyo, Japan
    • Hirata Internal Medicine Urology Clinic
  • Tokyo, Japan
    • J Tower Clinic
  • Tokyo, Japan
    • Koganeibashi Sakura Clinic
  • Tokyo, Japan
    • Kunitachi Sakura Hospital
  • Tokyo, Japan
    • Kusunoki Clinic
  • Tokyo, Japan
    • Moriguchi Clinic
  • Tokyo, Japan
    • Nakanoma Clinic Urology Department
  • Tokyo, Japan
    • Ogawa Clinic
  • Tokyo, Japan
    • Ogikubo Ekimae Clinic
  • Tokyo, Japan
    • Shibuya Shin-minamiguchi Clinic
  • Tokyo, Japan
    • Tokyo Kamata Hospital
  • Tokyo, Japan
    • Toru Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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
• Cancer
• 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
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL
• Renal insufficiency: Serum creatinine level >1.09 mg/dL; Estimated glomerular filtration rate <50 mL/min
• Hyponatraemia: Serum sodium level <135 mEq/L
• Central or nephrogenic diabetes insipidus
• Syndrome of inappropriate antidiuretic hormone
• Obstructive sleep apnea
• Previous desmopressin treatment
• Treatment with another investigational product within the past 3 months
• Concomitant treatment with any prohibited medication
• Alcohol or substance abuse
• A job or lifestyle that may interfere with regular night-time sleep
• A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A. Desmopressin 25 µg; 1 orally disintegrating tablet every night during study period	Drug: A: Desmopressin 25 µg
Active Comparator: B. Desmopressin 50 µg; 1 orally disintegrating tablet every night during study period	Drug: B. Desmopressin 50 µg
Placebo Comparator: C. Placebo; 1 orally disintegrating tablet every night during study period	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean number of nocturnal voids	During 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean time to first void	During 12 weeks
Responder status (33% reduction in nocturnal voids)	During 12 weeks
Change from baseline in mean number of nocturnal voids	1, 4, 8 and 12 weeks
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 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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 000030