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Phosphate Absorption Inhibitor

Tenapanor for Pediatric IBS with Constipation

Phase 3

Waitlist Available

Research Sponsored by Ardelyx

Eligibility Criteria Checklist

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

Must have

≥6 and <18 years old at enrollment of either parent study

Subject is ambulatory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies how safe a drug called tenapanor is for kids with a digestive condition called IBS-C.

Who is the study for?

This trial is for children and teenagers aged between 6 and under 18 who have Irritable Bowel Syndrome with Constipation (IBS-C). They must have completed a previous study on this condition, followed the procedures well, and be able to walk. Girls who can have babies need a negative pregnancy test and must use birth control.

What is being tested?

The trial is testing Tenapanor, which is being considered as a long-term treatment option for young patients with IBS-C. It's an open-label study, meaning everyone knows they're getting Tenapanor without any placebo or comparison drug involved.

What are the potential side effects?

While not specified here, common side effects of medications like Tenapanor could include digestive issues such as diarrhea or nausea, abdominal pain, headache, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 17 years old.

Select...

I can walk on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 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

Number of participants with treatment-related adverse events as assessed by MedDRA v26.0

Secondary study objectives

Change in alanine aminotransferase (ALT) serum chemistry value (IU/L)

Change in aspartate aminotransferase (AST) serum chemistry value (IU/L)

Change in serum creatinine value (mg/dL)

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT04549597

39%

Diarrhea

Acute Myocardial Infarction

Hyperkalemia

Dyspnoea

Covid-19

Cerebrovascular Accident

Fluid Overload

Chest Pain

Vascular Graft Occlusion

Sepsis

Hypoglycemia

Diabetic Foot

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1

Cohort 2

Cohort 3: Phosphate Binder Naïve

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TenapanorExperimental Treatment1 Intervention

Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per Investigator guidance after a patient's first week on the assigned dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tenapanor

2016

Completed Phase 4

~4040

0 / 2Eligibility criteria met