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
1 other identifier
interventional
183
1 country
35
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 23, 2013
August 1, 2013
9 months
September 11, 2012
August 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean number of nocturnal voids
During 12 weeks
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
A. Desmopressin 25 µg
ACTIVE COMPARATOR1 orally disintegrating tablet every night during study period
B. Desmopressin 50 µg
ACTIVE COMPARATOR1 orally disintegrating tablet every night during study period
C. Placebo
PLACEBO COMPARATOR1 orally disintegrating tablet every night during study period
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Clinic Tsudanuma
Chiba, Japan
University of Fukui Hospital
Fukui, Japan
Kato Clinic
Gunma, Japan
Umeyama Clinic
Gunma, Japan
Harada Urology Clinic
Hyōgo, Japan
Sakaguchi Urological Clinic
Hyōgo, Japan
Nakamura Urology Clinic
Kanagawa, Japan
Nishi-Yokohama International Hospital
Kanagawa, Japan
Yokohama Shinmidori General Hospital
Kanagawa, Japan
Izumino Hospital, Bouchikai
Kochi, Japan
Kamei Clinic
Kochi, 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
Osaka, Japan
Fukuda Clinic
Saitama, Japan
Yasuda Urology Clinic
Saitama, 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
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 27, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 23, 2013
Record last verified: 2013-08