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

NCT05643534 | Recruiting Phase 3 FDA Drug

• 1 other identifier: TEN-01-304
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Keywords

IBS-C

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (6)

• 6/12-week SBM +2 response

  12 weeks

• 6/12-week abdominal pain response

  12 weeks

• Change from baseline in average weekly SBM frequency

  12 weeks

• Change from baseline in average weekly stool consistency score

  12 weeks

• Change from baseline in average weekly abdominal pain score

  12 weeks

Study Arms (3)

Tenpanor 50 mg BID

EXPERIMENTAL

Patients will be randomized to receive 50 mg tenapanor twice daily

Drug: Tenapanor 50 MG

Tenpanor 25 mg BID

EXPERIMENTAL

Patients will be randomized to receive 25 mg tenapanor twice daily

Drug: Tenapanor 25 mg bid

Placebo Comparator

PLACEBO COMPARATOR

Patients will be randomized to receive matching placebo twice daily

Drug: Placebo

Interventions

Tenapanor 50 MG DRUG

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

Tenpanor 50 mg BID

Tenapanor 25 mg bid DRUG

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

Tenpanor 25 mg BID

Placebo DRUG

Participants will be randomized to receive matching placebo

Placebo Comparator

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (41)

G & L Research, LLC

Foley, Alabama, 36535, United States

COMPLETED

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

RECRUITING

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Prohealth Research Center

Doral, Florida, 33166, United States

RECRUITING

I.H.S. Health, LLC

Kissimmee, Florida, 34741, United States

TERMINATED

Waterway Research & Associates Corp

Miami, Florida, 33155, United States

RECRUITING

Valencia Medical and Research Center

Miami, Florida, 33165, United States

RECRUITING

Orlando Health, Inc.- APH Center for Digestive Health and Nutrition

Orlando, Florida, 32806, United States

RECRUITING

Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143, United States

RECRUITING

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

COMPLETED

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Riley Children's Health IUH

Indianapolis, Indiana, 46202, United States

RECRUITING

Maine Health

Portland, Maine, 04102, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mankato Clinic/ Javara Research Ltd

Mankato, Minnesota, 56001, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

WITHDRAWN

Boys Town National Research Hospital

Boys Town, Nebraska, 68010, United States

RECRUITING

Med Clinical Research Partners, LLC

Irvington, New Jersey, 07111, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

COMPLETED

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Advantage Clinical Trials

The Bronx, New York, 10467, United States

COMPLETED

Atrium Health

Charlotte, North Carolina, 28203, United States

RECRUITING

Duke University School of Medicine

Durham, North Carolina, 27705, United States

RECRUITING

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

WITHDRAWN

Wilmington Health

Wilmington, North Carolina, 28401, United States

RECRUITING

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

RECRUITING

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

RECRUITING

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

WITHDRAWN

Prisma Health Children's Hospital

Greenville, South Carolina, 29615, United States

RECRUITING

Advance Clinical Trial PLLC

Abilene, Texas, 79606, United States

RECRUITING

Maspons Pediatric Gastro

El Paso, Texas, 79902, United States

RECRUITING

Proactive El Paso, LLC

El Paso, Texas, 79902, United States

RECRUITING

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

RECRUITING

AIM Trials, LLC

Plano, Texas, 75093, United States

COMPLETED

Sun Research Institute

San Antonio, Texas, 78215, United States

RECRUITING

Pioneer Research Solutions Inc

Sugar Land, Texas, 77479, United States

RECRUITING

ClinPoint Trials

Waxahachie, Texas, 75165, United States

RECRUITING

University Physicians and Surgeons, Inc.

Huntington, West Virginia, 25701, United States

RECRUITING

Frontier Clinical Research

Kingwood, West Virginia, 26537, United States

RECRUITING

MeSH Terms

Interventions

tenapanor; BID protein, human

Study Officials

• Susan Edelstein, PhD

  Ardelyx

  STUDY DIRECTOR

Central Study Contacts

Jocelyn Tabora

CONTACT

510-745-1724; jtabora@ardelyx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)