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

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Information provided by: Johnson & Johnson Consumer and Personal Products Worldwide

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Enuresis	Drug: ibuprofen; pseudoephedrine HCl	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	318 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children
Actual Study Completion Date :	November 2002

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 11 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

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Study Director:	McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

More Information

Additional Information:

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

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ClinicalTrials.gov Identifier:	NCT00240812 History of Changes
Other Study ID Numbers:	CR002497
First Posted:	October 18, 2005
Last Update Posted:	June 29, 2011
Last Verified:	June 2011

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:

nocturnal enuresis; bedwetting; ibuprofen

Additional relevant MeSH terms:

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Enuresis; Urinary Incontinence; Nocturnal Enuresis; Urination Disorders; Urologic Diseases; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Ibuprofen; Pseudoephedrine; Ephedrine; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Nasal Decongestants