72 Participants Needed

Tenapanor for Irritable Bowel Syndrome with Constipation

Recruiting at 1 trial location
JT
SE
Overseen BySusan Edelstein, PhD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.23456

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.23456

Who Is on the Research Team?

DR

David Rosenbaum, PhD

Principal Investigator

Ardelyx

Are You a Good Fit for This Trial?

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
See 4 more

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.
See 9 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Tenapanor
Trial Overview 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.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Tenapanor Cohort 6Experimental Treatment1 Intervention
Tenapanor 25 mg BID
Group II: Tenapanor Cohort 5Experimental Treatment1 Intervention
Tenapanor 20 mg BID
Group III: Tenapanor Cohort 4Experimental Treatment1 Intervention
Tenapanor 15 mg BID
Group IV: Tenapanor Cohort 3Experimental Treatment1 Intervention
Tenapanor 10 mg BID
Group V: Tenapanor Cohort 2Experimental Treatment1 Intervention
Tenapanor 5 mg BID
Group VI: Tenapanor Cohort 1Experimental Treatment1 Intervention
Tenapanor 2 mg BID
Group VII: PlaceboPlacebo Group1 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

Who Is Running the Clinical Trial?

Ardelyx

Lead Sponsor

Trials
31
Recruited
6,100+

Published Research Related to This Trial

In a phase 3 trial involving 629 patients with constipation-predominant irritable bowel syndrome (IBS-C), tenapanor 50 mg twice daily significantly improved symptoms, with 27% of patients achieving the primary endpoint compared to 18.7% in the placebo group.
While tenapanor was generally well tolerated, diarrhea was the most common side effect, leading to discontinuation in 6.5% of patients, indicating a need for monitoring in clinical use.
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).Chey, WD., Lembo, AJ., Rosenbaum, DP.[2022]
In a phase 3 trial involving 620 patients with irritable bowel syndrome with constipation (IBS-C), tenapanor 50 mg twice daily significantly improved abdominal pain and bowel movement frequency compared to placebo, with 36.5% of patients responding positively versus 23.7% in the placebo group.
Tenapanor was generally well tolerated, with diarrhea being the most common side effect, but it was usually mild to moderate and led to discontinuation in only 6.5% of patients on tenapanor.
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).Chey, WD., Lembo, AJ., Yang, Y., et al.[2023]
Tenapanor is a first-in-class oral medication for treating irritable bowel syndrome with constipation (IBS-C) that works locally in the gut by inhibiting the NHE3 transporter, which may lead to fewer systemic side effects and drug interactions.
Clinical trials (Phase 2b and 3) have demonstrated that tenapanor effectively meets both primary and secondary treatment goals, suggesting it could be a promising new option for patients with IBS-C who find conventional laxatives unsatisfactory.
Tenapanor for the treatment of irritable bowel syndrome with constipation.Sinagra, E., Rossi, F., Raimondo, D., et al.[2022]

Citations

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). [2022]
Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). [2023]
Tenapanor for the treatment of irritable bowel syndrome with constipation. [2022]
Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. [2018]
Tenapanor hydrochloride for the treatment of constipation-predominant irritable bowel syndrome. [2018]
Tenapanor in the Treatment of Irritable Bowel Syndrome with Constipation: Discovery, Efficacy, and Role in Management. [2023]
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