Evidence map›Paper›PMID 39701047›Full record

Trial reportDigestive diseases (Basel, Switzerland)2025

Tenapanor Improves Abdominal Symptoms Irrespective of Changes in Complete Spontaneous Bowel Movement Frequency in Adults with Irritable Bowel Syndrome with Constipation.

Darren M Brenner, Gregory S Sayuk, Brooks D Cash, Lucinda A Harris, Nitin K Ahuja, Jill K Deutsch, Yang Yang, Suling Zhao, David P Rosenbaum, Anthony J Lembo

3 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Digestive diseases (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT01923428 phase2 / phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of AZD1722 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

TypeinterventionalSponsorArdelyxRan2013 to 2014Enrolled356ConditionsConstipation Predominant Irritable Bowel SyndromeArmsAZD1722, Placebo
NCT02621892 phase3completednot on this map

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

TypeinterventionalSponsorArdelyxRan2015 to 2017Enrolled606ConditionsConstipation Predominant Irritable Bowel SyndromeArmsTenapanor, Placebo
NCT02686138 phase3completednot on this map

A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

TypeinterventionalSponsorArdelyxRan2015 to 2017Enrolled593ConditionsConstipation Predominant Irritable Bowel SyndromeArmsTenapanor, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Animal cells and systems · 2025
    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

10 authors.

Darren M BrennerDivision of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Gregory S SayukDivision of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA.
Brooks D CashDivision of Gastroenterology, Hepatology, and Nutrition, University of Texas Health Science Center, Houston, Texas, USA.
Lucinda A HarrisMayo Clinic, Alix School of Medicine, Division of Gastroenterology and Hepatology, Scottsdale, Arizona, USA.
Nitin K AhujaDivision of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Jill K DeutschSection of Digestive Diseases, Department of Internal Medicine, Yale New Haven Hospital, Yale School of Medicine, New Haven, Connecticut, USA.
Yang YangArdelyx, Inc., Waltham, Massachusetts, USA.
Suling ZhaoArdelyx, Inc., Waltham, Massachusetts, USA.
David P RosenbaumArdelyx, Inc., Waltham, Massachusetts, USA.
Anthony J LemboDigestive Disease Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTenapanor is a first-in-class, minimally absorbed intestinal sodium/hydrogen exchanger isoform 3 inhibitor approved by the US Food and Drug Administration for adults with irritable bowel syndrome with constipation (IBS-C). Pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies examined the effects of tenapanor on abdominal symptoms independent of tenapanor's effect on complete spontaneous bowel movement (CSBM) frequency in adults with IBS-C.

methodsThis post hoc analysis was performed for patients with no CSBMs in ≥6 of the first 12 weeks of treatment (no-CSBM subgroup). The three-item abdominal score (AS3; the average of weekly abdominal pain, bloating, and discomfort scores) measured abdominal symptom response in tenapanor versus placebo. The overall change from baseline and response rate (improvement of ≥2 points or a reduction of ≥30%) in AS3 and individual abdominal scores during the 12 weeks were assessed.

resultsIn the pooled safety analysis set (N = 1,382), 641 patients were classified as no-CSBM patients and 640 were included in the efficacy analysis. Among the no-CSBM subgroup, tenapanor-treated patients experienced a greater improvement in AS3 in week 12 versus placebo-treated patients (least squares mean change, -1.74 vs. -1.29; p = 0.007), and the AS3 responder rate was higher for tenapanor (40.2% vs. 29.6%; p = 0.008). Similar improvements were displayed across individual abdominal symptom scores. Diarrhea was the most common adverse event in tenapanor-treated patients.

conclusionTenapanor was observed to improve abdominal symptoms independent of its effect on bowel symptoms in adults with IBS-C.

introductionTenapanor is a first-in-class, minimally absorbed intestinal sodium/hydrogen exchanger isoform 3 inhibitor approved by the US Food and Drug Administration for adults with irritable bowel syndrome with constipation (IBS-C). Pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies examined the effects of tenapanor on abdominal symptoms independent of tenapanor's effect on complete spontaneous bowel movement (CSBM) frequency in adults with IBS-C.

methodsThis post hoc analysis was performed for patients with no CSBMs in ≥6 of the first 12 weeks of treatment (no-CSBM subgroup). The three-item abdominal score (AS3; the average of weekly abdominal pain, bloating, and discomfort scores) measured abdominal symptom response in tenapanor versus placebo. The overall change from baseline and response rate (improvement of ≥2 points or a reduction of ≥30%) in AS3 and individual abdominal scores during the 12 weeks were assessed.

resultsIn the pooled safety analysis set (N = 1,382), 641 patients were classified as no-CSBM patients and 640 were included in the efficacy analysis. Among the no-CSBM subgroup, tenapanor-treated patients experienced a greater improvement in AS3 in week 12 versus placebo-treated patients (least squares mean change, -1.74 vs. -1.29; p = 0.007), and the AS3 responder rate was higher for tenapanor (40.2% vs. 29.6%; p = 0.008). Similar improvements were displayed across individual abdominal symptom scores. Diarrhea was the most common adverse event in tenapanor-treated patients.

conclusionTenapanor was observed to improve abdominal symptoms independent of its effect on bowel symptoms in adults with IBS-C.

Indexed as

ConstipationDefecationIrritable Bowel SyndromeSulfonamidesAbdominal PainAdultFemaleHumansIsoquinolinesMaleMiddle AgedTreatment OutcomeIsoquinolinesSulfonamidestenapanorAbdominal scoreAbdominal symptomsConstipationIrritable bowel syndromeTenapanor

Identifiers

PMID39701047
PMCPMC11965839

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.