Tenapanor for Irritable Bowel Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Kyle Staller, MD, MPH
Must not be taking: Opioids, Antidiabetics, IBS-C agents, others
Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop all current medications, but you must not use certain IBS-C treatments like linaclotide, lubiprostone, or plecanatide within a month before the trial. If you are taking probiotics, bulk laxatives, fiber, or stool softeners, your dose must be stable for at least 30 days before the trial and remain the same or decrease during the study.
What data supports the effectiveness of the drug Tenapanor for treating irritable bowel syndrome with constipation?
Research shows that Tenapanor, a drug approved by the FDA, helps improve bowel movement frequency and form, as well as reduce abdominal pain in patients with constipation-predominant irritable bowel syndrome (IBS-C). It works by increasing sodium levels in the intestines, which helps draw fluid into the gut and relieve constipation.
12345Is Tenapanor safe for humans?
Tenapanor has been tested in several clinical trials for irritable bowel syndrome with constipation (IBS-C) and has been approved by the FDA, indicating it is generally considered safe for this condition. It is minimally absorbed in the body, which may reduce the risk of side effects, but as with any medication, some people may experience side effects.
12346How is the drug Tenapanor unique for treating IBS-C?
Tenapanor is unique because it is a first-in-class drug that works by inhibiting the sodium/hydrogen exchanger in the gut, which increases sodium levels and fluid in the intestines, helping to relieve constipation and abdominal pain in IBS-C patients.
12345Eligibility Criteria
Adults aged 18-75 with IBS-C, as per Rome IV criteria for at least 6 months. Participants must be able to submit stool samples, follow instructions, record daily bowel habits, and have a BMI between >18.5 and <35 kg/m2. They should not make major dietary changes or use probiotics during the study.Inclusion Criteria
I have been diagnosed with constipation-predominant IBS for at least 6 months.
You have submitted a stool sample prior to starting medication.
You are willing to maintain your current dietary habits and use probiotics during the study period.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive tenapanor (50 mg per dose) twice daily for 8 weeks, with stool samples submitted at 0, 4, and 8 weeks
8 weeks
3 visits (sample submission)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Tenapanor's effects on gut bacteria and metabolism in IBS-C patients over an 8-week period. Subjects will take one capsule of Tenapanor (50 mg) twice daily and provide stool samples after weeks 4 and 8.
1Treatment groups
Experimental Treatment
Group I: Patients with IBS-CExperimental Treatment1 Intervention
Tenapanor is already approved in United States for the following indications:
🇺🇸 Approved in United States as Ibsrela for:
- Irritable Bowel Syndrome with Constipation (IBS-C)
- Chronic Kidney Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Kyle Staller, MD, MPHLead Sponsor
ArdelyxIndustry Sponsor
References
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). [2022]Tenapanor 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).
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). [2023]Tenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3. This phase 3 trial assessed the long-term efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C).
Tenapanor for constipation-predominant irritable bowel syndrome. [2020]Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders encountered in primary and secondary care and is associated with impaired quality of life, increased healthcare utilization, and significant costs to patients and society. There are three primary phenotypes of IBS, categorized according to stool pattern: IBS with diarrhea (IBS-D), IBS with constipation (IBS-C) and IBS with a mixed bowel pattern (IBS-M). The treatment approach to all forms of IBS is typically hierarchal, with initial therapies consisting of dietary and lifestyle modifications. When these interventions are impractical or ineffective, pharmacotherapy with over-the-counter and prescription therapies is often employed. Tenapanor is a locally acting, minimally absorbed, selective small-molecule inhibitor of the intestinal sodium/hydrogen exchanger 3 (NHE3) that was approved in September 2019 by the U.S. Food and Drug Administration (FDA) for IBS-C. This agent works by increasing the sodium level in the intestinal lumen and promoting the efflux of fluid into the gut lumen to maintain osmotic balance in addition to having an antinociceptive effect. Tenapanor has been shown to improve bowel movement frequency/form and abdominal pain in patients with IBS-C. This article will elaborate on the clinical development program for tenapanor for this indication.
Tenapanor: First Approval. [2020]The selective sodium hydrogen exchanger 3 (NHE3) inhibitor tenapanor is being developed by Ardelyx Inc. for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) [under the tradename IBSRELA®] and for hyperphosphataemia in patients with chronic kidney disease (CKD) on dialysis or with end stage renal disease (ESRD). Based on positive results from the phase III T3MPO trial program, tenapanor was recently approved in the USA for the treatment of IBS-C in adults. This article summarises the milestones in the development of tenapanor leading to this first approval.
Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. [2018]Tenapanor is a first-in-class, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger NHE3. This study assessed the efficacy and safety of tenapanor in patients with constipation-predominant irritable bowel syndrome (IBS-C).
Tenapanor in the Treatment of Irritable Bowel Syndrome with Constipation: Discovery, Efficacy, and Role in Management. [2023]Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction (DGBI). IBS significantly impacts the quality of life of patients. Since its pathogenesis is unclear and can be multifactorial, it highlights the need for new and improved pharmaceutical drugs that not only improve bowel symptoms, but also address global IBS symptoms, such as abdominal pain. Tenapanor, a recently Food & Drug Administration (FDA)-approved medication for IBS with constipation (IBS-C), is a small molecule inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3) that inhibits the absorption of sodium and phosphate in the gastrointestinal tract, resulting in fluid retention and softer stool. Furthermore, tenapanor reduces intestinal permeability to improve visceral hypersensitivity and abdominal pain. Due to its recent approval, tenapanor was not included in the recent IBS guidelines, however, it may be considered for IBS-C patients failing first-line treatment of soluble fiber. In this review article, we aim to provide in-depth information to the reader regarding the design of tenapanor, its development through Phase I, II and III randomized clinical trials, and its role in the treatment of IBS-C.