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

This study has been completed.
Sponsor:
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
  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:
  • FE992026
  • desmopressin melt
  • Minirin
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 April 21, 2014