Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women
- Registration Number
- NCT01684800
- 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 women during 12 weeks treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 178
- Has given written consent prior to any trial-related activity is performed.
- Female 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.
- Showing symptoms of any of the following diseases: 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.
- 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 >0.82 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.
- Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial.
- 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 A. Desmopressin 10 microgram A. Desmopressin 10 microgram -
- 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 (36)
Kanno Clinic
🇯🇵Osaka, Japan
Naka Clinic
🇯🇵Osaka, Japan
Ogikubo Ekimae Clinic
🇯🇵Tokyo, Japan
Shibuya Shin-minamiguchi Clinic
🇯🇵Tokyo, Japan
Tokyo Kamata Hospital
🇯🇵Tokyo, Japan
Toru Clinic
🇯🇵Tokyo, Japan
Yasuda Urology Clinic
🇯🇵Saitama, Japan
Hirata Internal Medicine Urology Clinic
🇯🇵Tokyo, Japan
Ogawa Clinic
🇯🇵Tokyo, Japan
Fukuda Clinic
🇯🇵Saitama, Japan
Umeyama Clinic
🇯🇵Gunma, Japan
Den Urology Clinic
🇯🇵Osaka, Japan
Iwasa Clinic
🇯🇵Osaka, Japan
Yamanaka Clinic
🇯🇵Osaka, Japan
Sakaguchi Urological Clinic
🇯🇵Hyogo, Japan
Nishi-Yokohama International Hospital
🇯🇵Kanagawa, Japan
Kamei Clinic
🇯🇵Kochi, Japan
Moriguchi Clinic
🇯🇵Tokyo, Japan
Clinic Tsudanuma
🇯🇵Chiba, Japan
Izumino Hospital, Bouchikai
🇯🇵Kochi, Japan
Morimoto Clinic
🇯🇵Osaka, Japan
Urology department Kuroda Clinic
🇯🇵Osaka, Japan
Japanese Red Cross Nagoya Daiichi Hospital
🇯🇵Aichi, Japan
University of Fukui Hospital
🇯🇵Fukui, Japan
Harada Urology Clinic
🇯🇵Hyogo, Japan
Nakamura Urology Clinic
🇯🇵Kanagawa, Japan
J Tower Clinic
🇯🇵Tokyo, Japan
Kato Clinic
🇯🇵Gunma, Japan
Yokohama Shinmidori General Hospital
🇯🇵Kanagawa, Japan
Uemura Clinic
🇯🇵Osaka, Japan
Yamaguchi Clinic
🇯🇵Osaka, Japan
Hirano Clinic
🇯🇵Tokyo, Japan
Koganeibashi Sakura Clinic
🇯🇵Tokyo, Japan
Kunitachi Sakura Hospital
🇯🇵Tokyo, Japan
Kusunoki Clinic
🇯🇵Tokyo, Japan
Nakanoma Clinic Urology Department
🇯🇵Tokyo, Japan