- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078753
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis (PNE)
September 27, 2011 updated by: Ferring Pharmaceuticals
A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
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."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Akita, Japan
- Akita University Hospital
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Hiroshima, Japan
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Niigata, Japan
- Aikawa Station Clinic
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Osaka, Japan
- Kitano Hospital
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Saitama, Japan
- Saitama Childrens Medical Centre
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Saitama, Japan
- Shintoshin Child Clinic
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Hyogo
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Amagasaki, Hyogo, Japan
- Showa Hospital
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Kakogawa, Hyogo, Japan
- Shinko-Kakogawa Hospital
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Ibaraki
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Mito, Ibaraki, Japan
- Tamura Children's Clinic
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Kanagawa
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Yokohama, Kanagawa, Japan
- Shinbo Child Clinic
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Osaka
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Hirakata, Osaka, Japan
- Kansai Medical University Hirakata Hospital
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Tokyo
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Musashino, Tokyo, Japan
- Takesue Children's Clinic
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Nerima, Tokyo, Japan
- Juntendo University Nerima Hospital
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Nishi-Tokyo, Tokyo, Japan
- Saitoh Pediatric Medical Clinic
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Setagaya, Tokyo, Japan
- Hoashi Children's Psychological Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
Other Names:
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Placebo Comparator: 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.
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Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Number of Wet Nights Between Baseline and Treatment Period II
Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
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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.
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Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Wet Nights Between Baseline and Treatment Period I
Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
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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.
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Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
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Change in Number of Wet Nights Between Treatment Periods I and II
Time Frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
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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.
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Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 1, 2010
First Posted (Estimate)
March 2, 2010
Study Record Updates
Last Update Posted (Estimate)
November 2, 2011
Last Update Submitted That Met QC Criteria
September 27, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
- Physiological Effects of Drugs
- Natriuretic Agents
- Hemostatics
- Coagulants
- Antidiuretic Agents
- Deamino Arginine Vasopressin
Other Study ID Numbers
- FE992026 CS35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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