Evidence map›Paper›PMID 31845426›Full record

Trial reportPediatrics international : official journal of the Japan Pediatric Society2020

Polyethylene glycol 3350 plus electrolytes for pediatric chronic constipation: An open-label clinical study in Japan.

Mayuko Gondo, Satoru Nagata, Kazuhiko Shinbo, Akira Oota, Takeshi Tomomasa

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Pediatrics international : official journal of the Japan Pediatric Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Treatments for intractable constipation in childhood.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Mayuko GondoDepartment of Pediatrics, Tokyo Women's Medical University, Tokyo, Japan.
Satoru NagataDepartment of Pediatrics, Tokyo Women's Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-2319-0885
Kazuhiko ShinboClinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.
Akira OotaClinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.
Takeshi TomomasaPal Children's Clinic, Gunma, Japan.
EA Pharma (Japan) · JPTokyo Women's Medical University · JPGunma Children's Medical Center · JP

Funding

EA Pharma Co., Ltd.
6 · The paper itself

Abstract

backgroundDespite 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.

methodsJapanese 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.

resultsThirty-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).

conclusionPEG3350+E can be considered as a new treatment option for chronic constipation in children in Japan. CLINICAL TRIAL REGISTRATION NUMBER: Japic CTI-163167.

Indexed as

Abdominal PainAdministration, OralAdolescentChildChild, PreschoolChronic DiseaseConstipationDiarrheaElectrolytesFemaleHumansJapanLaxativesMalePolyethylene GlycolsTreatment OutcomeElectrolytesLaxativespolyethylene glycol 3350Polyethylene GlycolsConstipationJapanpaediatricspolyethylene glycol 3350spontaneous bowel movement

Identifiers

PMID31845426
PMCPMC7317415
OpenAlexW2994653408

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.