Trial reportAlimentary pharmacology & therapeutics2017
Early response predicts a sustained response to eluxadoline in patients with irritable bowel syndrome with diarrhoea in two Phase 3 studies.
Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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.
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.
Who cites it
20 citing papers in PubMed, 26 citations in OpenAlex.
- Trial
- Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.Alimentary pharmacology & therapeutics · 2019Trial
- Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018Trial
- Irritable bowel syndrome management: current insights.Singapore medical journal · 2026Article
- Single-dose Pharmacokinetics of Eluxadoline in Healthy Participants With Normal Renal Function and Participants With Renal Impairment.Clinical pharmacology in drug development · 2023Article
- An Open-Label Study to Evaluate the Effect of Eluxadoline on the Single-Dose Pharmacokinetics of Midazolam in Healthy Participants.Clinical pharmacology in drug development · 2022Article
- Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial.Therapeutic advances in gastroenterology · 2022Article
- Review
- Improved work productivity and health-related quality of life in patients with irritable bowel syndrome with diarrhea receiving eluxadoline following inadequate response to loperamide.Journal of managed care & specialty pharmacy · 2021Article
- Diarrhea-Predominant Irritable Bowel Syndrome: Medical Management Update.Journal of the Canadian Association of Gastroenterology · 2020Article
- Pharmacological Therapies and Their Clinical Targets in Irritable Bowel Syndrome With Diarrhea.Frontiers in pharmacology · 2020Review
- Update on Eluxadoline for the Treatment of Irritable Bowel Syndrome with Diarrhea: Patient Selection and Perspectives.Drug design, development and therapy · 2020Review
- The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019Article
- Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials.Therapeutic advances in gastroenterology · 2019Article
- New treatments and therapeutic targets for IBS and other functional bowel disorders.Nature reviews. Gastroenterology & hepatology · 2018Review
- Use of Dietary Management in Irritable Bowel Syndrome: Results of a Survey of Over 1500 United States Gastroenterologists.Journal of neurogastroenterology and motility · 2018Article
- The place of eluxadoline in the management of irritable bowel syndrome with diarrhea.Therapeutic advances in gastroenterology · 2017Review
- Review
- Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome.Drug design, development and therapy · 2017Review
- Spotlight on eluxadoline for the treatment of patients with irritable bowel syndrome with diarrhea.Clinical and experimental gastroenterology · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, eluxadoline, is licensed in the USA for the treatment of irritable bowel syndrome with diarrhoea (IBS-D), based on the results of two large Phase 3 clinical trials.
aimTo understand the time course of treatment benefits with eluxadoline by comparing responder rates over the first month of treatment with responder rates over longer treatment intervals.
methodsIn this post hoc analysis of two Phase 3 studies, composite and adequate relief (AR) responder rates were calculated over month 1 and patients were stratified by their responder status. Cumulative counts over subsequent intervals (months 1-3, months 1-6, months 2 through 6) were tallied.
resultsThe studies randomised 2428 patients. Over month 1, 24.6%, 22.8% and 12.5% of patients were composite responders with eluxadoline 100 mg, eluxadoline 75 mg and placebo respectively. For month 1 responders, 77.8% and 81.5% (over months 1-3) and 70.7% and 73.9% (over months 1-6) showed a continuous response with eluxadoline 100 mg and 75 mg respectively. [Correction added on 5 April 2017, after first online publication: The percentage for the responders over months 1-3 was previously wrong and has been corrected.] Of the month 1 nonresponders, <20% showed a response over months 1-3 or months 1-6. Similar results were seen for the analysis of proportions of AR responders over these time intervals.
conclusionsOver two-thirds of patients who respond over the first month retain a positive response over 6 months of treatment with eluxadoline, indicating that early clinical response to eluxadoline is associated with sustained benefits for up to 6 months in patients with IBS-D.
Indexed as
Identifiers
What OpenQuestion holds
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.