Clinical trial NCT01694498: Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 183
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean number of nocturnal voids
timeFrame: During 12 weeks
Secondary outcomes:
measure: Change from baseline in mean time to first void
timeFrame: During 12 weeks
measure: Responder status (33% reduction in nocturnal voids)
timeFrame: During 12 weeks
measure: Change from baseline in mean number of nocturnal voids
timeFrame: 1, 4, 8 and 12 weeks
measure: Change from baseline in mean time to first void
timeFrame: 1, 4, 8 and 12 weeks
measure: Responder status (33% reduction in nocturnal voids)
timeFrame: 1, 4, 8 and 12 weeks
measure: Change from baseline in mean nocturnal urine volume
timeFrame: 1, 4, 8 and 12 weeks
measure: Change from baseline in nocturnal polyuria index
timeFrame: 1, 4, 8 and 12 weeks
measure: Change from baseline in the effect on sleep disturbance
timeFrame: 1, 4, 8 and 12 weeks
measure: Change from baseline in the impact on quality of life
timeFrame: 12 weeks
measure: Adverse events, changes from baseline in serum sodium level, laboratory values
timeFrame: During 12 weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Clinic Tsudanuma
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Gunma
country: Japan
facility: Kato Clinic
city: Gunma
country: Japan
facility: Umeyama Clinic
city: Hyogo
country: Japan
facility: Harada Urology Clinic
city: Hyogo
country: Japan
facility: Sakaguchi Urological Clinic
city: Kanagawa
country: Japan
facility: Nakamura Urology Clinic
city: Kanagawa
country: Japan
facility: Nishi-Yokohama International Hospital
city: Kanagawa
country: Japan
facility: Yokohama Shinmidori General Hospital
city: Kochi
country: Japan
facility: Izumino Hospital, Bouchikai
city: Kochi
country: Japan
facility: Kamei Clinic
city: Osaka
country: Japan
facility: Den Urology Clinic
city: Osaka
country: Japan
facility: Iwasa Clinic
city: Osaka
country: Japan
facility: Kanno Clinic
city: Osaka
country: Japan
facility: Morimoto Clinic
city: Osaka
country: Japan
facility: Naka Clinic
city: Osaka
country: Japan
facility: Uemura Clinic
city: Osaka
country: Japan
facility: Urology department Kuroda Clinic
city: Osaka
country: Japan
facility: Yamaguchi Clinic
city: Osaka
country: Japan
facility: Yamanaka Clinic
city: Saitama
country: Japan
facility: Fukuda Clinic
city: Saitama
country: Japan
facility: Yasuda Urology Clinic
city: Tokyo
country: Japan
facility: Hirano Clinic
city: Tokyo
country: Japan
facility: Hirata Internal Medicine Urology Clinic
city: Tokyo
country: Japan
facility: J Tower Clinic
city: Tokyo
country: Japan
facility: Koganeibashi Sakura Clinic
city: Tokyo
country: Japan
facility: Kunitachi Sakura Hospital
city: Tokyo
country: Japan
facility: Kusunoki Clinic
city: Tokyo
country: Japan
facility: Moriguchi Clinic
city: Tokyo
country: Japan
facility: Nakanoma Clinic Urology Department
city: Tokyo
country: Japan
facility: Ogawa Clinic
city: Tokyo
country: Japan
facility: Ogikubo Ekimae Clinic
city: Tokyo
country: Japan
facility: Shibuya Shin-minamiguchi Clinic
city: Tokyo
country: Japan
facility: Tokyo Kamata Hospital
city: Tokyo
country: Japan
facility: Toru Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: