4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

May 11, 2026 updated by: Ardelyx

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment.

During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period.

The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Applied Research Center of Arkansas
        • Contact:
        • Principal Investigator:
          • Sarah Bone, MD
    • Connecticut
    • Florida
      • Miami, Florida, United States, 33165
        • Recruiting
        • Valencia Medical and Research Center
        • Principal Investigator:
          • Inti Fernandez, MD
        • Contact:
      • Miami, Florida, United States, 33155
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health, Inc.- APH Center for Digestive Health and Nutrition
        • Principal Investigator:
          • Akash Pandey, MD
        • Contact:
      • South Miami, Florida, United States, 33143
        • Recruiting
        • Florida Pharmaceutical Research and Associates, Inc.
        • Contact:
        • Principal Investigator:
          • Ana Cantisano, MD
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Principal Investigator:
          • Manu Sood, MD
        • Contact:
    • Minnesota
      • Mankato, Minnesota, United States, 56001
    • Nebraska
      • Boys Town, Nebraska, United States, 68010
        • Recruiting
        • Boys Town National Research Hospital
        • Principal Investigator:
          • Jon Vanderhoof, MD
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • SUNY Downstate Medical Center
        • Principal Investigator:
          • Thomas Wallach, MD
        • Contact:
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kevin Watson, MD
    • South Carolina
      • Greenville, South Carolina, United States, 29615
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Maspons Pediatric Gastro
        • Contact:
        • Principal Investigator:
          • Aldo Maspons, MD
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Proactive El Paso, LLC
        • Contact:
        • Principal Investigator:
          • Eduardo Rosas-Blum, MD
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Texas Digestive Specialists
        • Contact:
        • Principal Investigator:
          • Mihaela Ringheanu, MD
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Sun Research Institute
        • Principal Investigator:
          • Leonel Reyes, MD
        • Contact:
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Pioneer Research Solutions Inc
        • Contact:
        • Principal Investigator:
          • Subodh Bhuchar, MD
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Clinical Research Partners, LLC
        • Principal Investigator:
          • Richard Bennett, MD
        • Contact:
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • University Physicians and Surgeons, Inc
        • Principal Investigator:
          • Xavier Villa, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥6 and <12 years old at the Screening visit (Visit 1)
  2. Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential.
  3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C
  4. 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)
  5. Meet the entry criteria assessed during the 2-week Screening period
  6. 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
  7. Patient must provide verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Exclusion Criteria:

  1. Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
  2. IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
  3. History of non-retentive fecal incontinence;
  4. Required manual disimpaction any time prior to randomization (after consent)
  5. Currently 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.

  6. Patient has any of the following conditions:

    1. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
    2. Cystic fibrosis;
    3. Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
    4. Down's syndrome or any other chromosomal disorder;
    5. Active anal fissure (Note: History of anal fissure is not an exclusion);
    6. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
    7. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
    8. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
    9. Lead toxicity, hypercalcemia;
    10. Neurodevelopmental disabilities
    11. Inflammatory bowel disease
    12. Childhood functional abdominal pain syndrome
    13. Childhood functional abdominal pain
    14. Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
    15. Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
    16. History of cancer other than treated basal cell carcinoma of the skin;
    17. History of diabetic neuropathy.
  7. 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.

  8. Patient has had surgery that meets any of the following criteria:

    1. Surgery to remove a segment of the GI tract at any time before the Screening Visit;
    2. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
    3. An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
    4. Other major surgery during the 30 days before the Screening Visit
  9. History of alcohol or substance abuse
  10. Participation in other clinical trials within 1 month prior to Screening
  11. 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
  12. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching Placebo solution
Experimental: Tenapanor Cohort 1
Tenapanor 2 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA
Experimental: Tenapanor Cohort 2
Tenapanor 5 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA
Experimental: Tenapanor Cohort 3
Tenapanor 10 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA
Experimental: Tenapanor Cohort 4
Tenapanor 15 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA
Experimental: Tenapanor Cohort 5
Tenapanor 20 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA
Experimental: Tenapanor Cohort 6
Tenapanor 25 mg BID
Drug: Tenapanor
Tenapanor 5 mg/mL solution
Other Names:
  • IBSRELA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average weekly SBM (week 4)
Time Frame: 4 weeks
Change from baseline in average weekly SBM frequency in Week 4
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average weekly SBM (weeks 1, 2 and 3)
Time Frame: 3 weeks
Change from baseline in average weekly SBM frequency in Week 1, Week 2, and Week 3
3 weeks
SBM Response
Time Frame: 6 weeks
Weekly ≥3 SBM response: achieving an average weekly SBM frequency ≥3 for a given week
6 weeks
Rescue medication
Time Frame: 6 weeks
Overall use of rescue medication
6 weeks
Stool consistency
Time Frame: 6 weeks

Percent change from baseline in average weekly stool consistency score in each week

Scale Range:

  1. one (1)= Rabbit droppings: separate hard lumps, like nuts (hard to pass)
  2. seven (7) for Gravy: watery, no solids pieces, entirely liquid"
6 weeks
Abdominal Pain Score
Time Frame: 6 weeks

Percent change from baseline in average weekly abdominal pain score in each week

Scale Range:

zero (0) = no pain and ten (10)= very severe abdominal pain
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Investigators

  • Study Director: Jocelyn Tabora, Ardelyx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEN-01-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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