Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men
- Conditions
- Nocturia
- Interventions
- Drug: PlaceboDrug: B. Desmopressin 50 µg
- Registration Number
- NCT01694498
- Lead Sponsor
- Ferring Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 183
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C. Placebo Placebo 1 orally disintegrating tablet every night during study period B. Desmopressin 50 µg B. Desmopressin 50 µg 1 orally disintegrating tablet every night during study period
- Primary Outcome Measures
Name Time Method Change from baseline in mean number of nocturnal voids During 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (35)
Harada Urology Clinic
🇯🇵Hyogo, Japan
Yokohama Shinmidori General Hospital
🇯🇵Kanagawa, Japan
Moriguchi Clinic
🇯🇵Tokyo, Japan
Nakanoma Clinic Urology Department
🇯🇵Tokyo, Japan
Morimoto Clinic
🇯🇵Osaka, Japan
Clinic Tsudanuma
🇯🇵Chiba, Japan
Kanno Clinic
🇯🇵Osaka, Japan
Yamanaka Clinic
🇯🇵Osaka, Japan
Toru Clinic
🇯🇵Tokyo, Japan
University of Fukui Hospital
🇯🇵Fukui, Japan
Kato Clinic
🇯🇵Gunma, Japan
Umeyama Clinic
🇯🇵Gunma, Japan
Sakaguchi Urological Clinic
🇯🇵Hyogo, Japan
Nakamura Urology Clinic
🇯🇵Kanagawa, Japan
Izumino Hospital, Bouchikai
🇯🇵Kochi, Japan
Kamei Clinic
🇯🇵Kochi, Japan
Hirata Internal Medicine Urology Clinic
🇯🇵Tokyo, Japan
Den Urology Clinic
🇯🇵Osaka, Japan
Iwasa Clinic
🇯🇵Osaka, Japan
Naka Clinic
🇯🇵Osaka, Japan
Fukuda Clinic
🇯🇵Saitama, Japan
Nishi-Yokohama International Hospital
🇯🇵Kanagawa, Japan
Urology department Kuroda Clinic
🇯🇵Osaka, Japan
Yamaguchi Clinic
🇯🇵Osaka, Japan
J Tower Clinic
🇯🇵Tokyo, Japan
Yasuda Urology Clinic
🇯🇵Saitama, Japan
Hirano Clinic
🇯🇵Tokyo, Japan
Koganeibashi Sakura Clinic
🇯🇵Tokyo, Japan
Kunitachi Sakura Hospital
🇯🇵Tokyo, Japan
Kusunoki Clinic
🇯🇵Tokyo, Japan
Ogikubo Ekimae Clinic
🇯🇵Tokyo, Japan
Shibuya Shin-minamiguchi Clinic
🇯🇵Tokyo, Japan
Ogawa Clinic
🇯🇵Tokyo, Japan
Tokyo Kamata Hospital
🇯🇵Tokyo, Japan
Uemura Clinic
🇯🇵Osaka, Japan