New drug could ease teen IBS constipation pain

NCT ID NCT05643534

Symptom relief Sponsor: Ardelyx Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests tenapanor, a drug that helps with constipation and belly pain, in 180 teenagers aged 12 to 17 with irritable bowel syndrome and constipation (IBS-C). Participants take either a low or high dose of tenapanor or a placebo twice daily for 12 weeks. The goal is to see if the drug improves bowel movement frequency and reduces abdominal pain compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tenapanor
What this could lead to: If it works, this could provide a new treatment option for teenagers with irritable bowel syndrome and constipation, helping to reduce belly pain and improve bowel movements.
What could go wrong: This is a relatively small, short-term study (12 weeks) in a specific age group. The drug may not work better than a placebo, and side effects are possible. Results may not apply to all patients.

Why investors are watching

Ardelyx is running a phase 3 trial of tenapanor in teenagers with irritable bowel syndrome with constipation. The drug is already approved for adults, so this pediatric study could expand its use to a younger group. For a small company, this readout matters because it tests whether the drug works and is safe in a new patient population.

If it works: If the trial succeeds, Ardelyx could seek approval to sell tenapanor to pediatric patients, adding a new group of users. That would broaden the drug's market beyond adults.

If it fails: If the trial fails or is delayed, Ardelyx would not gain that pediatric approval, and the drug's potential in this age group would be in doubt. Clinical trials often fail, so this outcome is a real risk.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

180 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Irritable bowel syndrome with constipation (IBS-C) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome with constipation (IBS-C)

Contacts and locations

Locations

AIM Trials, LLC

Plano, Texas, 75093, United States
Advance Clinical Trial PLLC

Abilene, Texas, 79606, United States
Advanced Research Center, Inc.

Anaheim, California, 92805, United States
Advantage Clinical Trials

The Bronx, New York, 10467, United States
Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States
Atrium Health

Charlotte, North Carolina, 28203, United States
Boston Children's Hospital

Boston, Massachusetts, 02115, United States
Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States
ClinPoint Trials

Waxahachie, Texas, 75165, United States
Clinical Research Institute

Stockbridge, Georgia, 30281, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Duke University School of Medicine

Durham, North Carolina, 27705, United States
Eclipse Clinical Research

Tucson, Arizona, 85745, United States
Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143, United States
Frontier Clinical Research

Kingwood, West Virginia, 26537, United States
Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States
G & L Research, LLC

Foley, Alabama, 36535, United States
I.H.S. Health, LLC

Kissimmee, Florida, 34741, United States
Maine Health

Portland, Maine, 04102, United States
Mankato Clinic/ Javara Research Ltd

Mankato, Minnesota, 56001, United States
Maspons Pediatric Gastro

El Paso, Texas, 79902, United States
Med Clinical Research Partners, LLC

Irvington, New Jersey, 07111, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition

Orlando, Florida, 32806, United States
Pioneer Research Solutions Inc

Sugar Land, Texas, 77479, United States
Prisma Health Children's Hospital

Greenville, South Carolina, 29615, United States
Proactive El Paso, LLC

El Paso, Texas, 79902, United States
Prohealth Research Center

Doral, Florida, 33166, United States
Riley Children's Health IUH

Indianapolis, Indiana, 46202, United States
SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States
Sun Research Institute

San Antonio, Texas, 78215, United States
Texas Digestive Specialists

Harlingen, Texas, 78550, United States
University Physicians and Surgeons, Inc.

Huntington, West Virginia, 25701, United States
University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States
University of Rochester

Rochester, New York, 14642, United States
Valencia Medical and Research Center

Miami, Florida, 33165, United States
Waterway Research & Associates Corp

Miami, Florida, 33155, United States
Wilmington Health

Wilmington, North Carolina, 28401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.