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

Phase 3

Completed

Brief 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."

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
Desmopressin	Desmopressin	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.

Primary Outcome Measures

Name	Time	Method
Change in the Number of Wet Nights Between Baseline and Treatment Period II	Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).	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.

Secondary Outcome Measures

Name	Time	Method
Change in Number of Wet Nights Between Baseline and Treatment Period I	Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).	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.
Change in Number of Wet Nights Between Treatment Periods I and II	Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)	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.

Locations (15): Kansai Medical University Hirakata Hospital
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Hirakata, Osaka, Japan
Tamura Children's Clinic
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Mito, Ibaraki, Japan
Shinbo Child Clinic
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Yokohama, Kanagawa, Japan
Juntendo University Nerima Hospital
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Nerima, Tokyo, Japan
Saitoh Pediatric Medical Clinic
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Nishi-Tokyo, Tokyo, Japan
Hoashi Children's Psychological Clinic
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Setagaya, Tokyo, Japan
Shinko-Kakogawa Hospital
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Kakogawa, Hyogo, Japan
Takesue Children's Clinic
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Musashino, Tokyo, Japan
Saitama Childrens Medical Centre
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Saitama, Japan
Akita University Hospital
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Akita, Japan
Kitano Hospital
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Osaka, Japan
Showa Hospital
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Amagasaki, Hyogo, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Hiroshima, Japan
Shintoshin Child Clinic
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Saitama, Japan
Aikawa Station Clinic
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Niigata, Japan