Evidence map›Paper›PMID 26800997›Full record

Trial reportJournal of gastroenterology2016

Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study.

Shin Fukudo, Yoshikazu Kinoshita, Toshikatsu Okumura, Motoko Ida, Kenta Hayashi, Hiraku Akiho, Yoshihiro Nakashima, Ken Haruma

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01736423 (A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT01736423 phase3completednot on this map

A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

TypeinterventionalSponsorAstellas Pharma IncRan2012 to 2014Enrolled151ConditionsDiarrhea-predominant Irritable Bowel SyndromeArmsYM060
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Sex-Gender Differences in Irritable Bowel Syndrome.Journal of neurogastroenterology and motility · 2018
    Review
  7. Review
  8. Acupuncture for Diarrhoea-Predominant Irritable Bowel Syndrome: A Network Meta-Analysis.Evidence-based complementary and alternative medicine : eCAM · 2018
    Review
  9. Review
  10. Article
  11. Article
  12. 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

8 authors at 5 institutions in 2 countries.

Shin FukudoDepartment of Behavioral Medicine, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan. sfukudo@med.tohoku.ac.jp.
Yoshikazu KinoshitaDepartment of Gastroenterology, Faculty of Medicine, Shimane University, Izumo, Japan.
Toshikatsu OkumuraDepartment of General Medicine, Asahikawa Medical University, Asahikawa, Japan.
Motoko IdaDevelopment Planning and Administration, Astellas Pharma Inc., Tokyo, Japan.
Kenta HayashiJapan/Asia Clinical Development 2, Astellas Pharma Inc., Tokyo, Japan.
Hiraku AkihoJapan/Asia Clinical Development 2, Astellas Pharma Inc., Tokyo, Japan.
Yoshihiro NakashimaData Science, Astellas Pharma Inc., Tokyo, Japan.
Ken HarumaDepartment of Gastroenterology, Kawasaki Medical School, Kurashiki, Japan.
Astellas Pharma (China) · CNAsahikawa Medical University · JPKawasaki Medical School · JPShimane University · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe long-term safety of administration of ramosetron in female patients with irritable bowel syndrome with diarrhea (IBS-D) is unknown. The aim of this study was to assess the long-term safety, tolerability, and outcomes with the use of ramosetron in female patients with IBS-D.

methodsThis was a phase III, open-label, uncontrolled, long-term safety trial of the treatment of female Japanese patients with IBS-D, diagnosed according to the Rome III criteria. A total of 151 patients were given 2.5 μg of ramosetron for 4 weeks, and responders continued the same dose for another 48 weeks. Non-responders at 4 weeks were given 5 μg of ramosetron for 48 weeks. At the end of week 52, 106 patients receiving 2.5 μg and 17 patients receiving 5 μg had completed the study. Safety and efficacy including symptoms and quality of life (QOL) were evaluated.

resultsConcerning safety, no serious adverse event related to ramosetron, specifically ischemic colitis, was observed in patients with either dose of ramosetron. However, constipation occurred in 19.7 % of patients given 2.5 μg and 10.5 % of patients given 5 μg of ramosetron. Ramosetron-treated patients showed high rates of global improvement. Stool consistency, abdominal pain and discomfort, and IBS-QOL were also improved at the last evaluation point.

conclusionsThe results provide evidence of the long-term safety and efficacy of treatment with 2.5 and 5 μg of ramosetron in female patients with IBS-D. Clinicians should be aware that one-fifth of women with IBS-D receiving ramosetron may suffer from constipation during treatment (ClinicalTrials.gov ID: NCT01736423).

Indexed as

AdultBenzimidazolesDiarrheaDrug Administration ScheduleFemaleHumansIrritable Bowel SyndromeMiddle AgedSerotonin AntagonistsTreatment OutcomeBenzimidazolesramosetronSerotonin Antagonists5-HydroxytryptamineAbdominal discomfortAbdominal painGlobal improvement

Identifiers

PMID26800997
OpenAlexW1971947202

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.