Irritable Bowel Syndrome With Constipation (IBS-C)Phase 3NCT05643534
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
A Phase 3 study testing Tenapanor 50 MG and Tenapanor 25 mg bid in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 39 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation (IBS-C)
- What is being tested?
- Tenapanor 50 MG and Tenapanor 25 mg bid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 39 sitesUnited States
- Study dates
- 15 Nov 2022to 20 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥12 and <18 years old
- Patient weighs ≥18 kg at the time the patient provides written assent
- Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
- Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
- Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
- Patient meets the entry criteria assessed during the 2-week Screening period.
- Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
- Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
Who cannot join
- Functional diarrhea as defined by Rome IV child/adolescent criteria
- IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria
- History of non-retentive fecal incontinence.
- Required manual disimpaction any time prior to randomization (after consent);
- Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
- Patient has any of the following conditions:
Show all 33Show fewer
- Celiac disease, or positive serological test for celiac disease
- Cystic fibrosis
- Hypothyroidism that is untreated or treated with thyroid hormone
- Down's syndrome or any other chromosomal disorder
- Active anal fissure
- Anatomic malformations (eg, imperforate anus)
- Intestinal nerve or muscle disorders (eg, Hirschprung disease)
- Neuropathic conditions (eg, spinal cord abnormalities)
- Lead toxicity, hypercalcemia
- Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device)
- Inflammatory bowel disease
- Childhood functional abdominal pain syndrome
- Childhood functional abdominal pain;
- Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
- Lactose intolerance that is associated with abdominal pain or discomfort
- History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.)
- History of diabetic neuropathy.
- Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator.
- Patient has had surgery that meets any of the following criteria:
- Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
- Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
- An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
- Other major surgery during the 30 days before the Screening Visit
- History of alcohol or substance abuse
- Participation in other clinical trials within 1 month prior to Screening
- Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial
- If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Advance Clinical Trial PLLC
Abilene, Texas, 79606
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Advanced Research Center, Inc.
Anaheim, California, 92805
Boston Children's Hospital
Boston, Massachusetts, 02115
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
Proactive El Paso, LLC
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
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
University Physicians and Surgeons, Inc.
Huntington, West Virginia, 25701
Riley Children's Health IUH
Indianapolis, Indiana, 46202
Med Clinical Research Partners, LLC
Irvington, New Jersey, 07111
Frontier Clinical Research
Kingwood, West Virginia, 26537
I.H.S. Health, LLC
Kissimmee, Florida, 34741
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205
Mankato Clinic/ Javara Research Ltd
Mankato, Minnesota, 56001
Waterway Research & Associates Corp
Miami, Florida, 33155
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
University of Rochester
Rochester, New York, 14642
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
Clinical Research Institute
Stockbridge, Georgia, 30281
Pioneer Research Solutions Inc
Sugar Land, Texas, 77479
Advantage Clinical Trials
The Bronx, New York, 10467
Eclipse Clinical Research
Tucson, Arizona, 85745
ClinPoint Trials
Waxahachie, Texas, 75165
Wilmington Health
Wilmington, North Carolina, 28401
About this study
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
Read the detailed description
This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP) and a 2-week treatment-free Follow-Up period (only for patients who will not enter the 40-week Long Term Safety Extension Study [TEN-01-306]). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening. Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg BID, tenapanor 50 mg BID, or placebo.
During the 12-week double-blind RTP, patients will continue recording daily assessments via the eDiary system as instructed and compliance with eDiary entries will be monitored on an ongoing basis. Patients will return for study visit every two or four weeks (Visits 3-6) and will undergo safety assessments at these visits.
Patients who do not enter the 40-week Long Term Safety Extension Study [TEN-01-306] including those who complete the RTP but do not enter study TEN-01-306 and those who prematurely discontinue from the RTP, a Follow-Up Visit will be scheduled approximately 2 weeks after the completion of the RTP (Visit 6) or the Early Termination Visit at which safety assessments will be performed
- Being tested
- Tenapanor 50 MG, Tenapanor 25 mg bid, Placebo
- Keywords
- IBS-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenapanor 50 MGDrug
Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
Tenapanor 25 mg bidDrug
Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
PlaceboDrug
Participants will be randomized to receive matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Tenpanor 50 mg BID | Experimental | Patients will be randomized to receive 50 mg tenapanor twice daily Receives: Drug: Tenapanor 50 MG |
| Tenpanor 25 mg BID | Experimental | Patients will be randomized to receive 25 mg tenapanor twice daily Receives: Drug: Tenapanor 25 mg bid |
| Placebo Comparator | Placebo comparator | Patients will be randomized to receive matching placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6/12-week APS (abdominal pain and SBM) +2 response
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP.
- The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week
- The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week
Measured: 12 weeks
Secondary outcomes (6)
6/12-week SBM +2 response
6/12-week SBM +2 response: defined as achieving the weekly SBM +2 response for ≥6 out of the 12 weeks of the RTP
Measured: 12 weeks
6/12-week abdominal pain response
6/12-week abdominal pain response: defined as achieving the weekly abdominal pain response for ≥6 out of the 12 weeks of the RTP
Measured: 12 weeks
Change from baseline in average weekly SBM frequency
Change from baseline in average weekly SBM frequency
Measured: 12 weeks
Change from baseline in average weekly stool consistency score
Change from baseline in average weekly stool consistency score
Measured: 12 weeks
Change from baseline in average weekly abdominal pain score
Change from baseline in average weekly abdominal pain score
Measured: 12 weeks
Overall use of rescue medication
Overall use of rescue medication
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Nov 2022
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
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
- NCT05643534
- Sponsor's protocol ID
- TEN-01-304
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old
- ClinicalTrials.gov ID
- NCT05643534
- Acronym / sponsor ID
- TEN-01-304
- Keywords
- IBS-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 8 Dec 2022 (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.
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
Detailed description
This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP) and a 2-week treatment-free Follow-Up period (only for patients who will not enter the 40-week Long Term Safety Extension Study [TEN-01-306]). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening. Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg BID, tenapanor 50 mg BID, or placebo.
During the 12-week double-blind RTP, patients will continue recording daily assessments via the eDiary system as instructed and compliance with eDiary entries will be monitored on an ongoing basis. Patients will return for study visit every two or four weeks (Visits 3-6) and will undergo safety assessments at these visits.
Patients who do not enter the 40-week Long Term Safety Extension Study [TEN-01-306] including those who complete the RTP but do not enter study TEN-01-306 and those who prematurely discontinue from the RTP, a Follow-Up Visit will be scheduled approximately 2 weeks after the completion of the RTP (Visit 6) or the Early Termination Visit at which safety assessments will be performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenpanor 50 mg BID | Experimental | Drug: Tenapanor 50 MGPatients will be randomized to receive 50 mg tenapanor twice daily |
| Tenpanor 25 mg BID | Experimental | Drug: Tenapanor 25 mg bidPatients will be randomized to receive 25 mg tenapanor twice daily |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPatients will be randomized to receive matching placebo twice daily |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- ≥12 and <18 years old
- Patient weighs ≥18 kg at the time the patient provides written assent
- Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
- Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
- Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
Key exclusion criteria (33 listed)
- Functional diarrhea as defined by Rome IV child/adolescent criteria
- IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria
- History of non-retentive fecal incontinence.
- Required manual disimpaction any time prior to randomization (after consent);
- Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
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 |
|---|---|---|
| Tenapanor 50 MGParticipants will receive tenapanor 50 mg BID (total of 100 mg daily) | Drug | Tenpanor 50 mg BID |
| Tenapanor 25 mg bidParticipants will receive tenapanor 25 mg BID (total of 50 mg daily) | Drug | Tenpanor 25 mg BID |
| PlaceboParticipants will be randomized to receive matching placebo | Drug | Placebo Comparator |
Primary outcome
6/12-week APS (abdominal pain and SBM) +2 response
Time frame: 12 weeks
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. * The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week * The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week
6 secondary outcomes
6/12-week SBM +2 response
Time frame: 12 weeks
6/12-week abdominal pain response
Time frame: 12 weeks
Change from baseline in average weekly SBM frequency
Time frame: 12 weeks
Change from baseline in average weekly stool consistency score
Time frame: 12 weeks
Change from baseline in average weekly abdominal pain score
Time frame: 12 weeks
Overall use of rescue medication
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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A Study of Virtual Reality and Linaclotide for IBS-C
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Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
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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. This study is not recruiting at the moment.
Jocelyn Tabora study director
Ardelyx
39 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 50 MG and Tenapanor 25 mg bid in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Ardelyx at 39 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 8 inclusion and 33 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: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6/12-week APS (abdominal pain and SBM) +2 response (time frame: 12 weeks). 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 22 Sep 2026.