A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting

Phase 2

Completed

• Conditions: Enuresis

• Registration Number: NCT00240812
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Brief Summary

The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.

Detailed Description

The objective of this double-blind, placebo-controlled, randomized, parallel-group study is to determine whether the effectiveness of ibuprofen in combination with pseudoephedrine HCl is greater than the individual drugs alone and greater than placebo for the treatment of nighttime bedwetting in children. After a screening visit, parents of eligible patients are to record in a diary, the number of urinations and wet and dry nights. Patients then return and those who continue to be eligible are randomized to study medication, which they will take for two weeks. Patients are randomized into four treatment groups, and the dose of treatment medication is determined based on body weight. The four treatment groups are: 12.5 mg of ibuprofen suspension/kg of body weight (200-450 mg of ibuprofen) plus 15 mg or 30 mg of pseudoephedrine HCl, 12.5 mg of ibuprofen suspension / kg of body weight (200 - 450 mg of ibuprofen) plus placebo suspension, or two doses of placebo suspension. The primary efficacy measurement is the mean reduction in wet nights, for the 14-day baseline period to the 14-day treatment period. Safety assessments consist of monitoring adverse events, physical examination and assessment of vital signs. The study hypothesis is that ibuprofen in combination with pseudoephedrine HCl has a greater effect in the treatment of nighttime bedwetting than either ibuprofen or pseudoephedrine HCl alone, and the combination is well tolerated. Treatment medication are an oral suspension, expressed as mg/kg body weight. Patients will receive 1 of 4 treatments for 2 weeks: ibuprofen (12.5 mg/kg of body weight) plus 15 or 30 mg of pseudoephedrine, ibuprofen (12.5 mg/kg of body weight) + placebo, 15 or 30 mg of pseudoephedrine, or placebo

Study Timeline

• Study Completion: 2002-11
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• Subject has nighttime bedwetting
• between the 5th and 95th percentiles for weight based on age and gender
• has a minimum of eight wet nights per 14 days of the baseline period
• healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests.

Exclusion Criteria

• Subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation)
• has had episodes of dryness lasting one month or longer, at any time in the past
• has a medical condition which may be relevant to participation in the study
• has a known sensitivity or allergy to the study medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with at least a 50% reduction in wet nights from baseline; the mean number of wet nights during the 14 days of treatment.