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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00240812
First received: October 14, 2005
Last updated: June 28, 2011
Last verified: June 2011

October 14, 2005
June 28, 2011
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The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.
Same as current
Complete list of historical versions of study NCT00240812 on ClinicalTrials.gov Archive Site
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.
Same as current
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A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Enuresis
Drug: ibuprofen; pseudoephedrine HCl
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
November 2002
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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.
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00240812
CR002497
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Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
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.
Johnson & Johnson Consumer and Personal Products Worldwide
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP