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

Last updated: January 15, 2025
Sponsor: Ardelyx
Overall Status: Active - Recruiting

Phase

2

Condition

Constipation

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

Tenapanor

Placebo

Clinical Study ID

NCT06553547
TEN-01-202
  • Ages 6-11
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofchild-bearing potential.

  3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis ofIBS-C

  4. Patient is willing to discontinue any laxatives used in favor of theprotocol-permitted rescue medicine (which will only be allowed after 72 hours withno 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 theInvestigator and to comply with the requirements of the entire study, including anunderstanding 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 writteninformed consent before the initiation of any study-specific procedures

Exclusion

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 byModified 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 (lowergastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool],iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemicsigns of infection or colitis, or any neoplastic process.

  6. Patient has any of the following conditions:

  7. Celiac disease, or positive serological test for celiac disease and thecondition has not been ruled out by endoscopic biopsy;

  8. Cystic fibrosis;

  9. Hypothyroidism that is untreated or treated with thyroid hormone at a dose thathas not been stable for at least 3 months prior to the Screening Visit;

  10. Down's syndrome or any other chromosomal disorder;

  11. Active anal fissure (Note: History of anal fissure is not an exclusion);

  12. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displacedanus);

  13. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceralmyopathies, visceral neuropathies);

  14. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis,tethered cord, spinal cord trauma);

  15. Lead toxicity, hypercalcemia;

  16. Neurodevelopmental disabilities

  17. Inflammatory bowel disease

  18. Childhood functional abdominal pain syndrome

  19. Childhood functional abdominal pain

  20. Poorly treated or poorly controlled psychiatric disorders that might influencehis or her ability to participate in the study;

  21. Lactose intolerance that is associated with abdominal pain or discomfort andcould confound the assessments in this study

  22. History of cancer other than treated basal cell carcinoma of the skin;

  23. History of diabetic neuropathy.

  24. Use of medications that are known to affect stool consistency (ProhibitedMedications), including fiber supplements, anti-diarrheals, cathartics, antacids,opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screeningperiod; unless specified as rescue medication, and used accordingly as directed bythe Investigator.

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

  26. Surgery to remove a segment of the GI tract at any time before the ScreeningVisit;

  27. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6months before the Screening Visit;

  28. An appendectomy or cholecystectomy during the 60 days before the ScreeningVisit;

  29. Other major surgery during the 30 days before the Screening Visit

  30. History of alcohol or substance abuse

  31. Participation in other clinical trials within 1 month prior to Screening

  32. Patient and/or parent/guardian/LAR is involved in the conduct and/or administrationof this trial as an investigator, sub-investigator, trial coordinator, or otherstaff member, or the patient is a first-degree family member, significant other, orrelative residing with one of the above persons involved in the trial

  33. If, in the opinion of the Investigator, the patient is unable or unwilling tofulfill the requirements of the protocol or has a condition, which would render theresults uninterpretable

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Tenapanor
Phase: 2
Study Start date:
July 24, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida 33143
    United States

    Active - Recruiting

  • Texas Digestive Specialists

    Harlingen, Texas 78550
    United States

    Active - Recruiting

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