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Small Molecule Inhibitor
Tenapanor for Irritable Bowel Syndrome
Phase 4
Recruiting
Research Sponsored by Kyle Staller, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Rome IV criteria for IBS-C for at least 6 months
Ages 18-75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial aims to understand how a medication called tenapanor affects the gut bacteria and chemicals in patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is a new medication
Who is the study for?
Adults aged 18-75 with IBS-C, as per Rome IV criteria for at least 6 months. Participants must be able to submit stool samples, follow instructions, record daily bowel habits, and have a BMI between >18.5 and <35 kg/m2. They should not make major dietary changes or use probiotics during the study.
What is being tested?
The trial is testing Tenapanor's effects on gut bacteria and metabolism in IBS-C patients over an 8-week period. Subjects will take one capsule of Tenapanor (50 mg) twice daily and provide stool samples after weeks 4 and 8.
What are the potential side effects?
Previous trials suggest that Tenapanor may lead to increased bowel movements and decreased abdominal pain; however, specific side effects are not listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with constipation-predominant IBS for at least 6 months.
Select...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will submit stool samples at 0 weeks, 4 weeks, and 8 weeks following treatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measuring metabolomics of stool samples using the DiscoveryHD4TM Platform
Measuring metagenomics of stool samples using whole genome shotgun sequencing (WGS)
Side effects data
From 2021 Phase 4 trial • 333 Patients • NCT0454959739%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with IBS-CExperimental Treatment1 Intervention
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?
Kyle Staller, MD, MPHLead Sponsor
ArdelyxIndustry Sponsor
29 Previous Clinical Trials
6,085 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
2,455 Patients Enrolled for Irritable Bowel Syndrome