Tenapanor for Irritable Bowel Syndrome with Constipation

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Ardelyx

Must not be taking: Fiber supplements, Anti-diarrheals

Disqualifiers: Celiac disease, Cystic fibrosis, Hypothyroidism, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called tenapanor in children who have IBS-C. The medication helps to soften stools, making it easier to relieve constipation.

Will I have to stop taking my current medications?

Participants will need to stop using laxatives and any medications that affect stool consistency, like fiber supplements and anti-diarrheals, unless specified as rescue medication by the study doctor.

What data supports the effectiveness of the drug Tenapanor for treating irritable bowel syndrome with constipation?

Research shows that Tenapanor, a drug that helps reduce sodium absorption in the gut, has been effective in treating irritable bowel syndrome with constipation (IBS-C) in multiple clinical trials, including both short-term (12-week) and long-term (26-week) studies, by improving symptoms like abdominal pain and bowel movement frequency.

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Is Tenapanor safe for humans?

Tenapanor has been studied in clinical trials for treating irritable bowel syndrome with constipation, and these trials have assessed its safety. It is minimally absorbed in the body, which may reduce the risk of side effects, and it has been approved by the FDA for this condition, indicating it has met safety standards.

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How is the drug Tenapanor unique for treating IBS-C?

Tenapanor is unique because it is a first-in-class drug that works by inhibiting a specific protein in the gut (NHE3), which reduces the absorption of sodium and water, helping to relieve constipation. Unlike other treatments that mainly address symptoms, Tenapanor targets the underlying process in the intestines, offering a novel approach for managing IBS-C.

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Eligibility Criteria

This trial is for kids and teens aged 12 to under 18 with IBS-C (constipation type). They must weigh at least 18 kg, not be pregnant, agree to use birth control if applicable, and can't have had certain surgeries or conditions that affect the gut. Participants need to stop other laxatives and follow study rules including using an eDiary.

Inclusion Criteria

I am between 12 and 17 years old.

Patient meets the entry criteria assessed during the 2-week Screening period

I and my guardian can communicate with the doctor and follow the study's requirements, including using an eDiary.

Exclusion Criteria

I have needed help to relieve severe constipation before joining the study.

I have been diagnosed with functional diarrhea according to Rome IV criteria.

History of non-retentive fecal incontinence

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive tenapanor or placebo twice daily for 12 weeks, with ongoing eDiary assessments and safety evaluations every two to four weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, unless they enter the Long Term Safety Extension Study

2 weeks

1 visit (in-person)

Long Term Safety Extension

Participants may opt into a 40-week extension study to continue receiving treatment and monitoring

40 weeks

Participant Groups

The trial tests two doses of Tenapanor (25 mg and 50 mg) against a placebo in young patients with IBS-C. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets which treatment. The medication is taken twice daily for three months.

Group I: Tenpanor 50 mg BID Experimental Treatment 1 Intervention

Patients will be randomized to receive 50 mg tenapanor twice daily

Group II: Tenpanor 25 mg BID Experimental Treatment 1 Intervention

Patients will be randomized to receive 25 mg tenapanor twice daily

Group III: Placebo Comparator Placebo Group 1 Intervention

Patients will be randomized to receive matching placebo twice daily

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 Nearby Select from list below to view details:

Texas Digestive Specialists Harlingen, TX

Atrium Health Charlotte, NC

Eclipse Clinical Research Tucson, AZ

Pioneer Research Solutions Inc Sugar Land, TX

More Trial Locations

Who Is Running the Clinical Trial?

Ardelyx Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

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).

2. United States pubmed.ncbi.nlm.nih.gov

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).

3. England pubmed.ncbi.nlm.nih.gov

Tenapanor for the treatment of irritable bowel syndrome with constipation. [2022] Irritable bowel syndrome with constipation is associated with higher rates of functional impairment, as compared to other subtypes of the syndrome. Conventional laxative-based pharmacologic therapy of IBS-C, which is mostly symptom-based, is often unsatisfactory. Tenapanor represents a first-in-class orally available inhibitor of NHE3, which is minimally absorbed in the GI tract, what constitutes a significant therapeutic benefit, as it may act on the drug target.

4. United States pubmed.ncbi.nlm.nih.gov

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).

5. England pubmed.ncbi.nlm.nih.gov

Tenapanor hydrochloride for the treatment of constipation-predominant irritable bowel syndrome. [2018] Constipation-predominant irritable bowel syndrome (IBS-C) is a common functional gastrointestinal (GI) disorder characterized by recurrent abdominal pain and prolonged GI transit. The pathogenesis of IBS-C has still not been established; therefore, drugs currently in use in IBS-C act mainly symptomatically, whereas novel pharmacological targets are urgently needed. Tenapanor is a potent inhibitor of Na(+)/H(+) exchanger 3 [NHE3], localized in the apical membrane of intestinal epithelial cells. NHE3 participates in the uptake of sodium ions and water from the intestinal lumen.

6. New Zealand pubmed.ncbi.nlm.nih.gov

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 &amp; 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.