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Tenapanor for Irritable Bowel Syndrome with Constipation

Phase 2
Recruiting
Research Sponsored by Ardelyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to discontinue any laxatives used in favor of the protocol-permitted rescue medicine
Age between 6 and 12 years old at the Screening visit
Must not have
Required manual disimpaction prior to randomization
Presence of unexplained and clinically significant alarm symptoms and systemic signs of infection or colitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

"This trial is testing a new medication called tenapanor to see if it is safe and effective for treating IBS-C in children aged 6 to 12 years old. It is a study where

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, common ones for IBS treatments may include abdominal pain, diarrhea or constipation changes, nausea, and reactions at administration sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop my current laxatives for the study's approved treatment.
Select...
I am between 6 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have undergone manual disimpaction before joining the study.
Select...
I have unexplained symptoms like weight loss or blood in stool.
Select...
I have been diagnosed with functional diarrhea according to the Modified Rome IV criteria.
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I have been diagnosed with a type of IBS according to Rome IV criteria.
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I have had recent major surgery in my abdomen or related areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Average weekly SBM (week 4)
Secondary study objectives
Abdominal Pain Score
Average weekly SBM (weeks 1, 2 and 3)
Rescue medication
+2 more

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT04549597
39%
Diarrhea
2%
Acute Myocardial Infarction
2%
Hyperkalemia
1%
Dyspnoea
1%
Covid-19
1%
Cerebrovascular Accident
1%
Fluid Overload
1%
Chest Pain
1%
Vascular Graft Occlusion
1%
Sepsis
1%
Hypoglycemia
1%
Diabetic Foot
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 2
Cohort 3: Phosphate Binder Naïve

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenapanor
2016
Completed Phase 4
~4040

Find a Location

Who is running the clinical trial?

ArdelyxLead Sponsor
29 Previous Clinical Trials
6,043 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
2,413 Patients Enrolled for Irritable Bowel Syndrome
David Rosenbaum, PhDStudy DirectorArdelyx
1 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
180 Patients Enrolled for Irritable Bowel Syndrome
~48 spots leftby Jun 2026
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