What side effects are associated with this type of intervention?

Common treatments for IBS, particularly those that increase intestinal fluid secretion and transit like Tenapanor, lubiprostone, and guanylate cyclase agonists (linaclotide, plecanatide), often have side effects such as diarrhea, abdominal pain, and bloating. Tenapanor specifically can cause diarrhea and abdominal distension. Lubiprostone may lead to nausea and headache, while linaclotide and plecanatide frequently cause diarrhea and sometimes abdominal discomfort. Antidiarrheals like loperamide can result in constipation and bloating, whereas bile acid sequestrants may cause gastrointestinal side effects including bloating, flatulence, and abdominal discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS), particularly for IBS with constipation (IBS-C). Linaclotide (Linzess) and plecanatide (Trulance) are guanylate cyclase-C agonists that increase intestinal fluid secretion and transit, similar to Tenapanor's mechanism of increasing water secretion into the intestines. Lubiprostone (Amitiza) is another approved drug that activates chloride channels to enhance fluid secretion in the gut. Alosetron (Lotronex) is a 5-HT3 receptor antagonist approved for IBS with diarrhea (IBS-D) in women, which works differently by slowing colonic transit. These treatments highlight the range of mechanisms targeting different aspects of IBS symptoms.

What other types of research exist?

Promising novel alternatives to Tenapanor for IBS patients include: 1) Glucagon-like peptide-1 receptor (GLP-1R) agonists, which have shown efficacy in reducing water and saline intake, potentially aiding in bowel regulation. 2) Curcuma longa, which has been studied for postprandial distress syndrome and may offer benefits for IBS symptoms. 3) Fiber supplements like psyllium or methylcellulose, which can improve stool consistency and alleviate constipation. These alternatives should be discussed with a healthcare provider to determine the best course of action based on individual patient needs.

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Phosphate Absorption Inhibitor

Tenapanor for Irritable Bowel Syndrome with Constipation

Phase 3

Recruiting

Research Sponsored by Ardelyx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones may include digestive issues like abdominal pain or discomfort due to Tenapanor's action on bowel movements. Side effects will be monitored closely throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6/12-week APS (abdominal pain and SBM) +2 response

Secondary study objectives

6/12-week SBM +2 response

6/12-week abdominal pain response

Change from baseline in average weekly SBM frequency

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tenpanor 50 mg BIDExperimental Treatment1 Intervention

Patients will be randomized to receive 50 mg tenapanor twice daily

Group II: Tenpanor 25 mg BIDExperimental Treatment1 Intervention

Patients will be randomized to receive 25 mg tenapanor twice daily

Group III: Placebo ComparatorPlacebo Group1 Intervention

Patients will be randomized to receive matching placebo twice daily

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Irritable Bowel Syndrome (IBS) work through various mechanisms to alleviate symptoms. Tenapanor, for example, inhibits the sodium/hydrogen exchanger 3 (NHE3) in the gut, reducing sodium absorption and increasing water secretion into the intestines, which helps alleviate constipation. Other treatments include 5-HT3 receptor antagonists like alosetron, which reduce bowel movement frequency and urgency by blocking serotonin signals in the gut. Antidiarrheals such as loperamide slow intestinal transit time and reduce stool frequency by inhibiting peristalsis. Bile acid sequestrants like colesevelam bind bile acids in the intestine, reducing diarrhea by decreasing colonic secretion and motility. Understanding these mechanisms is crucial for IBS patients as it helps tailor treatments to their specific symptoms, whether they are constipation-predominant, diarrhea-predominant, or a mix of both.

5-HT3 receptor antagonists. 3. Quinoline derivatives which may be effective in the therapy of irritable bowel syndrome.Differential expression of microRNA related to irritable bowel syndrome in a rabbit model.Oridonin Alleviates Visceral Hyperalgesia in a Rat Model of Postinflammatory Irritable Bowel Syndrome: Role of Colonic Enterochromaffin Cell and Serotonin Availability.

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Who is running the clinical trial?

ArdelyxLead Sponsor

29 Previous Clinical Trials

5,935 Total Patients Enrolled

8 Trials studying Irritable Bowel Syndrome

2,305 Patients Enrolled for Irritable Bowel Syndrome

David Rosenbaum, PhDStudy ChairArdelyx

1 Previous Clinical Trials

72 Total Patients Enrolled

1 Trials studying Irritable Bowel Syndrome

72 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Tenapanor (Phosphate Absorption Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05643534 — Phase 3

Irritable Bowel Syndrome Research Study Groups: Placebo Comparator, Tenpanor 50 mg BID, Tenpanor 25 mg BID

Irritable Bowel Syndrome Clinical Trial 2023: Tenapanor Highlights & Side Effects. Trial Name: NCT05643534 — Phase 3

Tenapanor (Phosphate Absorption Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643534 — Phase 3

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