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Polyethylene glycol 3350 plus electrolytes for pediatric chronic constipation: An open‐label clinical study in Japan
Author(s) -
Gondo Mayuko,
Nagata Satoru,
Shinbo Kazuhiko,
Oota Akira,
Tomomasa Takeshi
Publication year - 2020
Publication title -
pediatrics international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.49
H-Index - 63
eISSN - 1442-200X
pISSN - 1328-8067
DOI - 10.1111/ped.14102
Subject(s) - medicine , constipation , tolerability , adverse effect , functional constipation , chronic constipation , clinical endpoint , abdominal pain , diarrhea , clinical trial , defecation
Background Despite the abundance of study evidence for its efficacy and tolerability for the treatment of constipation in other countries, polyethylene glycol 3350 plus electrolytes (PEG3350+E) was not available in Japan until recently. The purpose of this study was to establish the efficacy and safety of PEG3350+E for the treatment of functional constipation in children in Japan. Methods Japanese children aged 2–14 years with a mean spontaneous bowel movement (SBM) frequency of 2 times/week or less for at least 2 months prior to informed consent were enrolled into the study. After a 2‐week screening period, treatment with PEG3350+E was initiated on the day of enrollment and continued for 12 weeks. Change in SBM frequency from screening period week 2 (baseline) to treatment period week 2 was set as the primary endpoint. Secondary endpoints and adverse events were also examined. Results Thirty‐nine patients were enrolled and completed the 12‐week study period. The SBM frequency (mean ± SD) at baseline and treatment period week 2 was 1.00 ± 0.89 and 6.54 ± 4.38, respectively. The change in SBM frequency was 5.54 ± 4.55 (one‐sample t test, P < 0.0001) and remained stable through week 12. Stool consistency was also improved over the entire treatment period. Three mild adverse drug reactions were reported: decreased appetite, abdominal pain, and diarrhea (each in 1 of 39 [2.6%] patients). Conclusion PEG3350+E can be considered as a new treatment option for chronic constipation in children in Japan. Clinical trial registration number: Japic CTI‐163167.