PEG3350 in the Treatment of Childhood Constipation: A Multicenter, Double-Blinded, Placebo-Controlled Trial
Received 7 July 2007; received in revised form 5 December 2007; accepted 29 January 2008. published online 20 March 2008.
Objective
To establish the efficacy and best starting dose of polyethylene glycol (PEG)3350 in the short-term treatment of children with functional constipation.
Study design
Prospective, randomized, multicenter, double-blinded, placebo-controlled, dose-ranging study of PEG3350 in children with functional constipation. Patients were randomly assigned to either placebo or 0.2 g/kg per day, 0.4 g/kg per day, or 0.8 g/kg per day of PEG3350 after a 1 week run-in period, followed by 2 weeks of treatment. All received behavior modification. The primary outcome was the proportion of patients with a successful treatment response: ≥3 bowel movements (BM) in the second week.
Results
103 children (mean, 8.5 ± 3.1 years) were enrolled. 77%, 74%, and 73% of the 0.2, 0.4, and 0.8 g/kg groups were successfully treated, as compared with 42% receiving placebo (P < .04). There was a significant increase in BM (P < .001) and straining improvement (P < .05) with the different PEG3350 doses. Stool consistency improved significantly for doses 0.4 g/kg or higher (P < .001).There was more abdominal pain and fecal incontinence in patients receiving 0.8 g/kg. PEG3350 was well tolerated.
Conclusions
This placebo-controlled study confirms the efficacy and safety of PEG3350 for the short-term treatment of children with functional constipation. We recommend a starting dose of 0.4 g/kg per day.
Reprint requests: Dr Samuel Nurko, Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital, 300 Longwood Avenue, Boston, MA 02115.
Supported in part by Braintree Laboratories, Inc, and by grants MO1-RR02172 from NCRR NIH to Children's Hospital Boston GCRC and grant M01 RR 000084 to Children's Hospital of Pittsburgh.
Conflict of Interest information available at www.jpeds.com.
The protocol was originally designed by the principal investigator (Dr Nurko), and later modifications occurred with input from Drs DiLorenzo, Youssef, and Sabri. After the protocol was finalized, it was submitted to the sponsor, who agreed to fund the project and participated in some later modifications of the protocol design. The collection of the data was done by the investigators. The analysis of the data was done in a joint fashion between the investigators and the sponsor. The interpretation of the data was done by the investigators. The first draft of the manuscript was written by Dr Nurko, and there was no honorarium involved in the production of the manuscript. Later drafts were modified by the other investigators. The sponsors reviewed the manuscript but did not modify its main content, message, or conclusions. The decision to submit for publication and where to submit were done by the investigators, without any input form the sponsor. The results and publication were not influenced by the sponsor in any way.
ABSTRACT