Evidence map›Paper›PMID 31934897›Full record

Trial reportThe American journal of gastroenterology2020

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).

William D Chey, Anthony J Lembo, David P Rosenbaum

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
10.4field-weighted citation impact, top 1% 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.

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
NCT06460038 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

TypeinterventionalSponsorCedar Valley Digestive Health CenterRan2025 to 2027Enrolled30ConditionsSynucleinopathy, Parkinson's DiseaseArmsTenapanor, Placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 101 citations in OpenAlex.

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  19. Patient-Centered Approach in IBS-C Management.Gastroenterology & hepatology · 2025
    Article
  20. Raising Expectations in IBS-C Management.Gastroenterology & hepatology · 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

3 authors at 3 institutions in 1 country.

William D CheyDivision of Gastroenterology, Department of Medicine, University of Michigan Health System, Ann Arbor, Michigan, USA.
Anthony J LemboDivision of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
David P RosenbaumArdelyx, Inc., Fremont, California, USA.
Ardelyx (United States) · USHarvard University · USMichigan Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3. This phase 3 trial assessed the efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with constipation-predominant irritable bowel syndrome (IBS-C).

methodsIn this phase 3, double-blind study (ClinicalTrials.gov identifier NCT02621892), patients with IBS-C were randomized to tenapanor 50 mg b.i.d. or placebo b.i.d. for 12 weeks followed by a 4-week randomized withdrawal period. The primary efficacy variable was the proportion of patients who reported a reduction in average weekly worst abdominal pain of ≥30.0% and an increase of ≥1 complete spontaneous bowel movement from baseline, both in the same week, for ≥6 weeks of the 12-week treatment period.

resultsOf the 629 randomized patients with IBS-C, 606 (96.3%) were included in the intention-to-treat analysis set (tenapanor: n = 307; placebo: n = 299) and 533 (84.7%) completed the 12-week treatment period. In the intention-to-treat analysis set (mean age 45 years, 81.4% women), a significantly greater proportion of patients treated with tenapanor met the primary endpoint than patients treated with placebo (27.0% vs 18.7%, P = 0.020). Abdominal symptoms and global symptoms of IBS also improved with tenapanor (P < 0.05 vs placebo). Diarrhea was the most commonly reported adverse event, resulting in study drug discontinuation in 6.5% and 0.7% of patients receiving tenapanor and placebo, respectively, during the 12-week treatment period. DISCUSSION: Tenapanor 50 mg b.i.d. improved IBS-C symptoms and was generally well tolerated, offering a potential new treatment option for patients with IBS-C.

Indexed as

Abdominal PainAdultConstipationDeprescriptionsDiarrheaDouble-Blind MethodFemaleHumansIrritable Bowel SyndromeIsoquinolinesMaleMiddle AgedSodium-Hydrogen Exchanger 3SulfonamidesTreatment OutcomeIsoquinolinesSodium-Hydrogen Exchanger 3Sulfonamidestenapanor

Identifiers

PMID31934897
PMCPMC7771640
OpenAlexW2999005407

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.