Irritable Bowel Syndrome With Constipation (IBS-C)Phase 3NCT05905926
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
A Phase 3 study testing Tenapanor in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 27 sites in United States.
Trial summary
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation (IBS-C)
- What is being tested?
- Tenapanor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesUnited States
- Study dates
- 17 Feb 2023to Oct 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥6 and <18 years old at enrollment of either parent study
- Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
- Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
- Subject is ambulatory
- Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
Who cannot join
- Patient discontinued prematurely from the parent study.
- Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
- Pregnant or lactating women
- If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites
Advance Clinical Trial PLLC
Abilene, Texas, 79606
Advanced Research Center, Inc.
Anaheim, California, 92805
Boys Town National Research Hospital
Boys Town, Nebraska, 68010
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Atrium Health
Charlotte, North Carolina, 28203
Prohealth Research Center
Doral, Florida, 33166
Duke University School of Medicine
Durham, North Carolina, 27705
Maspons Pediatric Gastro
El Paso, Texas, 79902
G & L Research, LLC
Foley, Alabama, 36535
Prisma Health Children's Hospital
Greenville, South Carolina, 29615
Texas Digestive Specialists
Harlingen, Texas, 78550
Riley Children's Health
Indianapolis, Indiana, 46202
Frontier Clinical Research
Kingwood, West Virginia, 26537
I.H.S. Health, LLC
Kissimmee, Florida, 34741
Mankato Clinic/ Javara Research Ltd
Mankato, Minnesota, 56001
Valencia Medical and Research Center
Miami, Florida, 33165
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
Orlando, Florida, 32806
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
AIM Trials, LLC
Plano, Texas, 75093
Maine Health
Portland, Maine, 04102
Sun Research Institute
San Antonio, Texas, 78215
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, 33143
Pioneer Research Solutions Inc
Sugar Land, Texas, 77479
Advantage Clinical Trials
The Bronx, New York, 10467
Wilmington Health
Wilmington, North Carolina, 28401
About this study
Official title: An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Read the detailed description
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.
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 guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
- Being tested
- Tenapanor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Also called Ibsrela
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Tenapanor | Experimental | 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. Receives: Drug: Tenapanor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measure Assessment (Adverse Event)
Incidence of AEs, SAEs and drug related adverse events
Measured: 40 weeks
Safety Measure Assessment (ECG)
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start17 Feb 2023
- Primary completionJul 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With Constipation (IBS-C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jocelyn Tabora, Study director, Ardelyx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905926
- Sponsor's protocol ID
- TEN-01-306
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
- ClinicalTrials.gov ID
- NCT05905926
- Acronym / sponsor ID
- TEN-01-306
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Detailed description
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.
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 guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| Tenapanor | Experimental | Drug: TenapanorEligible 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ≥6 and <18 years old at enrollment of either parent study
- Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator
- Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence).
- Subject is ambulatory
- Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
Key exclusion criteria (4 listed)
- Patient discontinued prematurely from the parent study.
- Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy
- Pregnant or lactating women
- If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenapanorAlso: IbsrelaEligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID | Drug | Tenapanor |
Primary outcome
Safety Measure Assessment (Adverse Event)
Time frame: 40 weeks
Incidence of AEs, SAEs and drug related adverse events
Safety Measure Assessment (ECG)
Time frame: 40 weeks
Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jocelyn Tabora study director
Ardelyx
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenapanor in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure Assessment (Adverse Event) (time frame: 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.