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

Ferring

Status and phase: Completed; Phase 2

Conditions: Nocturia

Treatments: Drug: A: Desmopressin 25 µg; Drug: Placebo; Drug: B. Desmopressin 50 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01694498

000030

Details and patient eligibility

About

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

Enrollment: 183 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 3 patient groups, including a placebo group

A. Desmopressin 25 µg

Active Comparator group

Description:

1 orally disintegrating tablet every night during study period

Treatment:

Drug: A: Desmopressin 25 µg

B. Desmopressin 50 µg

Active Comparator group

Description:

1 orally disintegrating tablet every night during study period

Treatment:

Drug: B. Desmopressin 50 µg

C. Placebo

Placebo Comparator group

Description:

1 orally disintegrating tablet every night during study period

Treatment:

Drug: Placebo