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

NCT01078753 | Completed Phase 3 Results

• 1 other identifier: FE992026 CS35
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• Change in the Number of Wet Nights Between Baseline and Treatment Period II

  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.

  Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).

Secondary Outcomes (2)

• Change in Number of Wet Nights Between Baseline and Treatment Period I

  Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).

• Change in Number of Wet Nights Between Treatment Periods I and II

  Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)

Study Arms (2)

Desmopressin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Desmopressin DRUG

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

Also known as: FE992026, desmopressin melt, Minirin

Desmopressin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

Akita University Hospital

Akita, Akita, Japan

Location

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Location

Showa Hospital

Amagasaki, Hyōgo, Japan

Location

Shinko-Kakogawa Hospital

Kakogawa, Hyōgo, Japan

Location

Tamura Children's Clinic

Mito, Ibaraki, Japan

Location

Shinbo Child Clinic

Yokohama, Kanagawa, Japan

Location

Aikawa Station Clinic

Niigata, Niigata, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, Japan

Location

Kitano Hospital

Osaka, Osaka, Japan

Location

Saitama Childrens Medical Centre

Saitama, Saitama, Japan

Location

Shintoshin Child Clinic

Saitama, Saitama, Japan

Location

Takesue Children's Clinic

Musashino, Tokyo, Japan

Location

Juntendo University Nerima Hospital

Nerima City, Tokyo, Japan

Location

Saitoh Pediatric Medical Clinic

Nishitōkyō, Tokyo, Japan

Location

Hoashi Children's Psychological Clinic

Setagaya City, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 40728007 DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 2, 2011
• Results First Posted: November 2, 2011

Record last verified: 2011-09

Locations

JP (15)