RECRUITING

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

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)IBS-C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old

Quick Facts

Study Start:2022-11-15

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05643534

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.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jocelyn Tabora

CONTACT

510-745-1724

jtabora@ardelyx.com

Susan Edelstein, PhD

CONTACT

510-456-7741

sedelstein@ardelyx.com

Principal Investigator

David Rosenbaum, PhD

STUDY_CHAIR

Ardelyx

Study Locations (Sites)

G & L Research, LLC

Foley, Alabama, 36535

United States

Eclipse Clinical Research

Tucson, Arizona, 85745

United States

Advanced Research Center, Inc.

Anaheim, California, 92805

United States

Prohealth Research Center

Doral, Florida, 33166

United States

I.H.S. Health, LLC

Kissimmee, Florida, 34741

United States

Valencia Medical and Research Center

Miami, Florida, 33165

United States

Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143

United States

Clinical Research Institute

Stockbridge, Georgia, 30281

United States

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

Boys Town National Research Hospital

Boys Town, Nebraska, 68010

United States

Med Clinical Research Partners, LLC

Irvington, New Jersey, 07111

United States

UNM Clinical and Translational Science Center

Albuquerque, New Mexico, 87131

United States

Advantage Clinical Trials

Bronx, New York, 10467

United States

SUNY Downstate Medical Center

Brooklyn, New York, 11203

United States

Atrium Health

Charlotte, North Carolina, 28203

United States

M3 Wake Research, Inc

Raleigh, North Carolina, 27612

United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683

United States

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478

United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818

United States

Prisma Health Children's Hospital

Greenville, South Carolina, 29615

United States

Advance Clinical Trial PLLC

Abilene, Texas, 79606

United States

Texas Digestive Specialists

Harlingen, Texas, 78550

United States

AIM Trials, LLC

Plano, Texas, 75093

United States

Sun Research Institute

San Antonio, Texas, 78215

United States

Pioneer Research Solutions Inc

Sugar Land, Texas, 77479

United States

ClinPoint Trials

Waxahachie, Texas, 75165

United States

University Physicians and Surgeons, Inc.

Huntington, West Virginia, 25701

United States

Frontier Clinical Research

Kingwood, West Virginia, 26537

United States

Collaborators and Investigators

Sponsor: Ardelyx

David Rosenbaum, PhD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2022-11-15

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-11-15

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

IBS-C

Additional Relevant MeSH Terms

Irritable Bowel Syndrome With Constipation (IBS-C)