Tenapanor for Irritable Bowel Syndrome with Constipation

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ardelyx

Must not be taking: Fiber supplements, Anti-diarrheals

Disqualifiers: Celiac, Cystic fibrosis, Hypothyroidism, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Will I have to stop taking my current medications?

Participants will need to stop taking any laxatives and medications that affect stool consistency, like fiber supplements, anti-diarrheals, and certain others, 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 works by blocking a specific sodium transporter in the gut, has been effective in reducing symptoms of irritable bowel syndrome with constipation in several clinical trials, including both short-term (12-week) and long-term (26-week) studies.

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Is Tenapanor safe for humans?

Tenapanor has been evaluated in clinical trials for irritable bowel syndrome with constipation, and these studies 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, called the sodium/hydrogen exchanger 3 (NHE3), which helps reduce the absorption of sodium and water, thereby easing constipation. Unlike traditional treatments that mainly address symptoms, Tenapanor targets a novel mechanism in the gut, offering a new approach for managing IBS-C.

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Eligibility Criteria

This trial is for children aged 6 to less than 12 years who have Irritable Bowel Syndrome with Constipation (IBS-C). The key eligibility details are not provided, so it's important to check the specific requirements before joining.

Inclusion Criteria

I am willing to stop my current laxatives for the study's approved treatment.

Meet the entry criteria assessed during the 2-week Screening period

Verbal assent from patient and written informed consent from parent/guardian/LAR before study-specific procedures

Exclusion Criteria

Involvement in the conduct or administration of the trial by patient or parent/guardian/LAR

I have undergone manual disimpaction before joining the study.

I have a medical condition like celiac disease or hypothyroidism, but not well-treated cancer or diabetic neuropathy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Randomized Treatment Period

Participants receive tenapanor or placebo and record daily assessments in the eDiary

4 weeks

4 visits (in-person)

Follow-up

Participants undergo a treatment-free period with safety assessments

2 weeks

1 visit (in-person)

Participant Groups

The study is testing the safety and effectiveness of a medication called Tenapanor compared to a placebo. It's designed as a double-blind test, meaning neither the participants nor the researchers know who receives the real drug or placebo.

Group I: Tenapanor Cohort 6 Experimental Treatment 1 Intervention

Tenapanor 25 mg BID

Group II: Tenapanor Cohort 5 Experimental Treatment 1 Intervention

Tenapanor 20 mg BID

Group III: Tenapanor Cohort 4 Experimental Treatment 1 Intervention

Tenapanor 15 mg BID

Group IV: Tenapanor Cohort 3 Experimental Treatment 1 Intervention

Tenapanor 10 mg BID

Group V: Tenapanor Cohort 2 Experimental Treatment 1 Intervention

Tenapanor 5 mg BID

Group VI: Tenapanor Cohort 1 Experimental Treatment 1 Intervention

Tenapanor 2 mg BID

Group VII: Placebo Placebo Group 1 Intervention

Matching placebo

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:

Florida Pharmaceutical Research and Associates, Inc. South Miami, FL

Texas Digestive Specialists Harlingen, TX

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.