Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Last updated: December 12, 2024
Sponsor: Ardelyx
Overall Status: Active - Enrolling

Phase

3

Condition

Constipation

Colic

Lactose Intolerance

Treatment

Tenapanor

Clinical Study ID

NCT05905926
TEN-01-306
  • Ages 6-18
  • All Genders

Study Summary

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥6 and <18 years old at enrollment of either parent study

  2. Patient completed the parent study immediately with adequate compliance with studyprocedures in the opinion of the Investigator

  3. Females of child-bearing potential must have negative pregnancy test at the lastvisit of the parent study and confirm the use of appropriate contraception (including abstinence).

  4. Subject is ambulatory

  5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR)and a willingness of both subject and parent/guardian/LAR to participate in thestudy as it is described

Exclusion

Exclusion Criteria:

  1. Patient discontinued prematurely from the parent study.

  2. Any surgery on the stomach, small intestine or colon, excluding appendectomy orcholecystectomy

  3. Pregnant or lactating women

  4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfillthe requirements of the protocol

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Tenapanor
Phase: 3
Study Start date:
February 17, 2023
Estimated Completion Date:
October 31, 2031

Study Description

Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study.

Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.

Connect with a study center

  • G & L Research, LLC

    Foley, Alabama 36535
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • Prohealth Research Center

    Doral, Florida 33166
    United States

    Site Not Available

  • I.H.S. Health, LLC

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Valencia Medical and Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida 33143
    United States

    Site Not Available

  • Boys Town National Research Hospital

    Boys Town, Nebraska 68010
    United States

    Site Not Available

  • Advantage Clinical Trials

    Bronx, New York 10467
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Prisma Health Children's Hospital

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Texas Digestive Specialists

    Harlingen, Texas 78550
    United States

    Site Not Available

  • AIM Trials, LLC

    Plano, Texas 75093
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Pioneer Research Solutions Inc

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Frontier Clinical Research

    Kingwood, West Virginia 26537
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia 26537
    United States

    Site Not Available

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