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

A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis

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."

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