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

Primary Purpose

Nocturnal Enuresis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Desmopressin
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Enuresis

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Showa Hospital
  • Shinko-Kakogawa Hospital
  • Tamura Children's Clinic
  • Shinbo Child Clinic
  • Kansai Medical University Hirakata Hospital
  • Takesue Children's Clinic
  • Juntendo University Nerima Hospital
  • Saitoh Pediatric Medical Clinic
  • Hoashi Children's Psychological Clinic
  • Akita University Hospital
  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Aikawa Station Clinic
  • Kitano Hospital
  • Saitama Childrens Medical Centre
  • Shintoshin Child Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desmopressin

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 1, 2010
Last Updated
September 27, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01078753
Brief Title
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
FE992026, desmopressin melt, Minirin
Intervention Description
Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
Primary Outcome Measure Information:
Title
Change in the Number of Wet Nights Between Baseline and Treatment Period II
Description
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.
Time Frame
Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
Secondary Outcome Measure Information:
Title
Change in Number of Wet Nights Between Baseline and Treatment Period I
Description
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.
Time Frame
Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
Title
Change in Number of Wet Nights Between Treatment Periods I and II
Description
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.
Time Frame
Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Showa Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Shinko-Kakogawa Hospital
City
Kakogawa
State/Province
Hyogo
Country
Japan
Facility Name
Tamura Children's Clinic
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Shinbo Child Clinic
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kansai Medical University Hirakata Hospital
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Takesue Children's Clinic
City
Musashino
State/Province
Tokyo
Country
Japan
Facility Name
Juntendo University Nerima Hospital
City
Nerima
State/Province
Tokyo
Country
Japan
Facility Name
Saitoh Pediatric Medical Clinic
City
Nishi-Tokyo
State/Province
Tokyo
Country
Japan
Facility Name
Hoashi Children's Psychological Clinic
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Facility Name
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
City
Hiroshima
Country
Japan
Facility Name
Aikawa Station Clinic
City
Niigata
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
Country
Japan
Facility Name
Saitama Childrens Medical Centre
City
Saitama
Country
Japan
Facility Name
Shintoshin Child Clinic
City
Saitama
Country
Japan

12. IPD Sharing Statement

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

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