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

Nocturia Clinical Trial

— NOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694498
• Other study ID #: 000030
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2012
• Last updated: August 22, 2013
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• A: Desmopressin 25 µg

• B. Desmopressin 50 µg

• Placebo

Locations

Country	Name	City	State
Japan	Clinic Tsudanuma	Chiba
Japan	University of Fukui Hospital	Fukui
Japan	Kato Clinic	Gunma
Japan	Umeyama Clinic	Gunma
Japan	Harada Urology Clinic	Hyogo
Japan	Sakaguchi Urological Clinic	Hyogo
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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of nocturnal voids		During 12 weeks	No
Secondary	Change from baseline in mean time to first void		During 12 weeks	No
Secondary	Responder status (33% reduction in nocturnal voids)		During 12 weeks	No
Secondary	Change from baseline in mean number of nocturnal voids		1, 4, 8 and 12 weeks	No
Secondary	Change from baseline in mean time to first void		1, 4, 8 and 12 weeks	No
Secondary	Responder status (33% reduction in nocturnal voids)		1, 4, 8 and 12 weeks	No
Secondary	Change from baseline in mean nocturnal urine volume		1, 4, 8 and 12 weeks	No
Secondary	Change from baseline in nocturnal polyuria index		1, 4, 8 and 12 weeks	No
Secondary	Change from baseline in the effect on sleep disturbance		1, 4, 8 and 12 weeks	No
Secondary	Change from baseline in the impact on quality of life		12 weeks	No
Secondary	Adverse events, changes from baseline in serum sodium level, laboratory values		During 12 weeks	Yes