Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation (IBS-C)

In brief

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.

Key facts

Study ID

NCT05643534

Run by

Ardelyx

People needed

180

Starts

2022-11-15

Expected to finish

2026-09-01

Last updated by the study team

2026-06-04

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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:

Where it is running

• G & L Research, LLC — Foley, Alabama, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Prohealth Research Center — Doral, Florida, United States
• I.H.S. Health, LLC — Kissimmee, Florida, United States
• Waterway Research & Associates Corp — Miami, Florida, United States
• Valencia Medical and Research Center — Miami, Florida, United States
• Orlando Health, Inc.- APH Center for Digestive Health and Nutrition — Orlando, Florida, United States
• Florida Pharmaceutical Research and Associates, Inc. — South Miami, Florida, United States
• Clinical Research Institute — Stockbridge, Georgia, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Riley Children's Health IUH — Indianapolis, Indiana, United States
• Maine Health — Portland, Maine, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Mankato Clinic/ Javara Research Ltd — Mankato, Minnesota, United States
• Boys Town National Research Hospital — Boys Town, Nebraska, United States
• Med Clinical Research Partners, LLC — Irvington, New Jersey, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• University of Rochester — Rochester, New York, United States
• Advantage Clinical Trials — The Bronx, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Duke University School of Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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