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A Randomized, Placebo-Controlled, Exploratory Trial of Ibuprofen and Pseudoephedrine in the Treatment of Primary Nocturnal Enuresis in Children

Clinical Research and Biometrics, McNeil Consumer Healthcare, Fort Washington, Pennsylvania

Mary Jane Prior, PhD, MPH

Clinical Research and Biometrics, McNeil Consumer Healthcare, Fort Washington, Pennsylvania, mprior{at}its.jnj.com

Joan Gu, MS

Drug Development and Safety, McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, Pennsylvania

This exploratory randomized, double-blind, double-dummy, placebo-controlled trial of 14 days duration conducted in 22 primary care practices in the United States was used to compare the efficacy of ibuprofen and pseudoephedrine, administered alone or in combination, to placebo for the treatment of primary nocturnal enuresis (PNE) in children aged 6 to 11 years. Ibuprofen (IBU) and pseudoephedrine (PSE) are not approved for the treatment of PNE. Three hundred eighteen children with PNE were enrolled. Eligible children had 8 wet nights during a 14-day baseline. Each child was randomly assigned to 1 of 4 treatment groups: IBU 12.5 mg/kg and PSE HCl 15 or 30 mg (depending on weight) (n = 82), IBU 12.5 mg/kg (n = 78), PSE HCl 15 or 30 mg (n = 76), or placebo (n = 82). Treatment was administered orally at bedtime for 14 days. Caregivers recorded whether the child was wet or dry each night in a daily diary. Children in the IBU alone and IBU and PSE combined groups had greater mean reductions from baseline in the number of wet nights (primary end point) compared to children receiving placebo (-2.9, -2.9, and -1.4, respectively, P < .005); PSE alone (-1.8) was not significantly different from placebo. Children in these groups also had greater mean percentage reductions in the number of wet nights compared to placebo-treated children (26%, 28%, and 12%, respectively). Although not always statistically significant, secondary end points improved in the IBU alone and IBU and PSE combined treatment groups, which included decreases in mean number of wet nights and decreases in the number and percentage of children with 50%, 40%, 30%, or 25% reductions in number of wet nights. Children responding to treatment had larger mean bladder capacities and larger mean percentage of predicted bladder capacities than children who did not respond in each treatment group. No significant differences in adverse events were found among treatment groups. In conclusion, in this exploratory study in children aged 6 through 11 years, IBU provided a beneficial effect in the treatment of PNE compared to placebo, whereas PSE did not. The addition of PSE to IBU did not enhance or diminish the efficacy of IBU. All treatments were well tolerated.

Key Words: nocturnal enuresis • pediatric • ibuprofen • pseudoephedrine • randomized controlled trial

This version was published on May 1, 2009

Clinical Pediatrics, Vol. 48, No. 4, 410-419 (2009)
DOI: 10.1177/0009922809332593


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