Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Deamino Arginine Vasopressin

Criteria

Inclusion Criteria:

• Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality

• Age 6 or above but under 16 regardless of gender

• Out-patient

• Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week

• Deemed healthy by the investigator

• Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol

• Consent from the pediatric patient's legally acceptable representative

• Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility

• Show no possibility of being a nursing mother or pregnant, or becoming pregnant

• If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment

Exclusion Criteria:

• Suffer from enuresis with an underlying disease

• Participated in another clinical trial within six months preceding consent

• Used an intranasal Desmopressin in the past

• Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder

• Have an anomaly or a disease that may affect the oral absorption of drug products

• Hard to get cooperation from subject by school refusal, punishment or bullying

• Deemed by the investigator to be inappropriate to participate in this trial

• Unable to be placed on water-intake restriction starting from two hours before bedtime

• Evidence of hepatic, renal, cardiac, or pulmonary dysfunction