ArticleBioPsychoSocial medicine2017
Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea.
Article in BioPsychoSocial medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00918411 (Post-marketing Clinical Study of Ramosetron Hydrochloride), which is not on this map. Cited by 2 papers.
What it found
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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.
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.
Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
Who cites it
2 citing papers in PubMed, 7 citations in OpenAlex.
- Irritable bowel syndrome management: current insights.Singapore medical journal · 2026Article
- Update on Pharmacotherapy for Irritable Bowel Syndrome.Current gastroenterology reports · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGlobal assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess "clinically meaningful improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D).
methodsThe same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of ramosetron (
resultsRates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point,
conclusionsRamosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).
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