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

Nocturnal Enuresis Clinical Trial

— PNE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078753
• Other study ID #: FE992026 CS35
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2010
• Last updated: September 27, 2011
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Intervention

Drug:
• Desmopressin
Desmopressin oral lyophilisate tablet, 120 µg or 240 µg, administered sublingually once a day 1½ hours before bedtime.
• Placebo
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	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)	No