Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis (PNE)
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01078753
First received: March 1, 2010
Last updated: September 27, 2011
Last verified: September 2011
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Purpose
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."
| Condition | Intervention | Phase |
|---|---|---|
|
Nocturnal Enuresis |
Drug: Desmopressin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) ] [ Designated as safety issue: No ]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.
| Enrollment: | 89 |
| Study Start Date: | January 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Desmopressin
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.
|
Drug: Placebo
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
|
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078753
Locations
| Japan | |
| Showa Hospital | |
| Amagasaki, Hyogo, Japan | |
| Shinko-Kakogawa Hospital | |
| Kakogawa, Hyogo, Japan | |
| Tamura Children's Clinic | |
| Mito, Ibaraki, Japan | |
| Shinbo Child Clinic | |
| Yokohama, Kanagawa, Japan | |
| Kansai Medical University Hirakata Hospital | |
| Hirakata, Osaka, Japan | |
| Takesue Children's Clinic | |
| Musashino, Tokyo, Japan | |
| Juntendo University Nerima Hospital | |
| Nerima, Tokyo, Japan | |
| Saitoh Pediatric Medical Clinic | |
| Nishi-Tokyo, Tokyo, Japan | |
| Hoashi Children's Psychological Clinic | |
| Setagaya, Tokyo, Japan | |
| Akita University Hospital | |
| Akita, Japan | |
| Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital | |
| Hiroshima, Japan | |
| Aikawa Station Clinic | |
| Niigata, Japan | |
| Kitano Hospital | |
| Osaka, Japan | |
| Shintoshin Child Clinic | |
| Saitama, Japan | |
| Saitama Childrens Medical Centre | |
| Saitama, Japan | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01078753 History of Changes |
| Other Study ID Numbers: | FE992026 CS35 |
| Study First Received: | March 1, 2010 |
| Results First Received: | September 27, 2011 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Enuresis Nocturnal Enuresis Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Deamino Arginine Vasopressin |
Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013