We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00240812
First Posted: October 18, 2005
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Consumer and Personal Products Worldwide
October 14, 2005
October 18, 2005
June 29, 2011
Not Provided
Not Provided
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
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Enuresis
Drug: ibuprofen; pseudoephedrine HCl
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
November 2002
Not Provided

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.
Sexes Eligible for Study: All
6 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00240812
CR002497
Not Provided
Not Provided
Not Provided
Not Provided
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