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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin<br>During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. | Drug: Desmopressin<br>* Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.<br>* Other names: Minirin;|
| Placebo Comparator: Placebo<br>Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. | Drug: Placebo<br>* Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Number of Wet Nights Between Baseline and Treatment Period II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II. | Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Wet Nights Between Baseline and Treatment Period I | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I. | Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). | 
| Change in Number of Wet Nights Between Treatment Periods I and II | The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II. | Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) |