Status:
COMPLETED
A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Enuresis
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
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 indi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00240812
End Date
November 1 2002
Last Update
June 29 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.