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

NCT ID: NCT01078753

Last Updated: 2011-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-09-30

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."

Conditions

Nocturnal Enuresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Interventions

Desmopressin

Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.

Intervention Type: DRUG

Placebo

Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Intervention Type: DRUG

Other Intervention Names

FE992026; desmopressin melt; Minirin

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Akita University Hospital

Akita, Akita, Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Showa Hospital

Amagasaki, Hyōgo, Japan

Shinko-Kakogawa Hospital

Kakogawa, Hyōgo, Japan

Tamura Children's Clinic

Mito, Ibaraki, Japan

Shinbo Child Clinic

Yokohama, Kanagawa, Japan

Aikawa Station Clinic

Niigata, Niigata, Japan

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, Japan

Kitano Hospital

Osaka, Osaka, Japan

Saitama Childrens Medical Centre

Saitama, Saitama, Japan

Shintoshin Child Clinic

Saitama, Saitama, Japan

Takesue Children's Clinic

Musashino, Tokyo, Japan

Juntendo University Nerima Hospital

Nerima City, Tokyo, Japan

Saitoh Pediatric Medical Clinic

Nishitōkyō, Tokyo, Japan

Hoashi Children's Psychological Clinic

Setagaya City, Tokyo, Japan

Countries

Japan

References

Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.

Reference Type: DERIVED

PMID: 40728007 (View on PubMed)

Other Identifiers

FE992026 CS35

Identifier Type: -

Identifier Source: org_study_id