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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Ephedrine; Ibuprofen; Pseudoephedrine

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.