Clinical trial NCT01078753: Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Official title: A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturnal Enuresis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 89
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."


Eligibility 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

Primary outcomes:
measure: Change in the Number of Wet Nights Between Baseline and Treatment Period II
timeFrame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
Secondary outcomes:
measure: Change in Number of Wet Nights Between Baseline and Treatment Period I
timeFrame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
measure: Change in Number of Wet Nights Between Treatment Periods I and II
timeFrame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Showa Hospital
state: Hyogo
city: Kakogawa
country: Japan
facility: Shinko-Kakogawa Hospital
state: Hyogo
city: Mito
country: Japan
facility: Tamura Children's Clinic
state: Ibaraki
city: Yokohama
country: Japan
facility: Shinbo Child Clinic
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hirakata Hospital
state: Osaka
city: Musashino
country: Japan
facility: Takesue Children's Clinic
state: Tokyo
city: Nerima
country: Japan
facility: Juntendo University Nerima Hospital
state: Tokyo
city: Nishi-Tokyo
country: Japan
facility: Saitoh Pediatric Medical Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Hoashi Children's Psychological Clinic
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
city: Niigata
country: Japan
facility: Aikawa Station Clinic
city: Osaka
country: Japan
facility: Kitano Hospital
city: Saitama
country: Japan
facility: Saitama Childrens Medical Centre
city: Saitama
country: Japan
facility: Shintoshin Child Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: