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Clinical Trials in the USA / NCT05643534
Active, not recruiting Phase 3

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

NCT05643534 · tracked via the Priya Life Science USA tracker
Sponsor
Ardelyx
Phase
Phase 3
Started
2022-11-15
Last updated
2026-06-04

Condition(s) studied

Irritable Bowel Syndrome With Constipation (IBS-C)

Investigational drug(s) / intervention(s)

Tenapanor 50 MGTenapanor 25 mg bidPlacebo

Tenapanor 50 MG: Participants will receive tenapanor 50 mg BID (total of 100 mg daily)

Tenapanor 25 mg bid: Participants will receive tenapanor 25 mg BID (total of 50 mg daily)

Placebo: Participants will be randomized to receive matching placebo

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
G & L Research, LLC Foley Alabama
Eclipse Clinical Research Tucson Arizona
Applied Research Center of Arkansas Little Rock Arkansas
Advanced Research Center, Inc. Anaheim California
Connecticut Children's Medical Center Hartford Connecticut
Prohealth Research Center Doral Florida
I.H.S. Health, LLC Kissimmee Florida
Waterway Research & Associates Corp Miami Florida
Valencia Medical and Research Center Miami Florida
Orlando Health, Inc.- APH Center for Digestive Health and Nutrition Orlando Florida
Florida Pharmaceutical Research and Associates, Inc. South Miami Florida
Clinical Research Institute Stockbridge Georgia
OSF Saint Francis Medical Center Peoria Illinois
Riley Children's Health IUH Indianapolis Indiana
Maine Health Portland Maine
Boston Children's Hospital Boston Massachusetts
Mankato Clinic/ Javara Research Ltd Mankato Minnesota
Boys Town National Research Hospital Boys Town Nebraska
Med Clinical Research Partners, LLC Irvington New Jersey
University of New Mexico Health Sciences Center Albuquerque New Mexico
SUNY Downstate Medical Center Brooklyn New York
University of Rochester Rochester New York
Advantage Clinical Trials The Bronx New York
Atrium Health Charlotte North Carolina
Duke University School of Medicine Durham North Carolina
Wilmington Health Wilmington North Carolina
Frontier Clinical Research, LLC Scottdale Pennsylvania
Frontier Clinical Research, LLC Smithfield Pennsylvania
Prisma Health Children's Hospital Greenville South Carolina
Advance Clinical Trial PLLC Abilene Texas
Maspons Pediatric Gastro El Paso Texas
Proactive El Paso, LLC El Paso Texas
Texas Digestive Specialists Harlingen Texas
AIM Trials, LLC Plano Texas
Sun Research Institute San Antonio Texas
Pioneer Research Solutions Inc Sugar Land Texas
ClinPoint Trials Waxahachie Texas
University Physicians and Surgeons, Inc. Huntington West Virginia
Frontier Clinical Research Kingwood West Virginia

More Ardelyx trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05643534 on ClinicalTrials.gov ↗ ← All trials in the USA