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

• ClinicalTrials.gov Identifier: NCT01078753
• Recruitment Status: Completed
• First Posted: March 2, 2010
• Results First Posted: November 2, 2011
• Last Update Posted: November 2, 2011
• Sponsor: Ferring Pharmaceuticals
• Information provided by (Responsible Party): Ferring Pharmaceuticals

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."

Condition or disease	Intervention/treatment	Phase
Nocturnal Enuresis	Drug: Desmopressin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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). ]
   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 :

1. 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). ]
   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.
2. 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• 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

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

Saitama Childrens Medical Centre

Saitama, Japan

Shintoshin Child Clinic

Saitama, Japan

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support; Ferring Pharmaceuticals

More Information

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01078753
• Other Study ID Numbers: FE992026 CS35
• First Posted: March 2, 2010
• Results First Posted: November 2, 2011
• Last Update Posted: November 2, 2011
• Last Verified: September 2011

Additional relevant MeSH terms:

Enuresis; Urinary Incontinence; Nocturnal Enuresis; Urination Disorders; Urologic Diseases; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Deamino Arginine Vasopressin; Hemostatics; Coagulants; Antidiuretic Agents; Natriuretic Agents; Physiological Effects of Drugs