Enuresis Clinical Trial
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
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.
Status | Completed |
Enrollment | 318 |
Est. completion date | November 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 11 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer and Personal Products Worldwide |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period. | |||
Secondary | 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. |
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