RECRUITING

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

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 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.

Official Title

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

Quick Facts

Study Start:2024-07-24

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06553547

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:6 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Jocelyn Tabora

CONTACT

510-745-1724

jtabora@ardelyx.com

Susan Edelstein, PhD

CONTACT

617-913-4964

sedelstein@ardelyx.com

Principal Investigator

David Rosenbaum, PhD

STUDY_DIRECTOR

Ardelyx

Study Locations (Sites)

Florida Pharmaceutical Research and Associates, Inc.

South Miami, Florida, 33143

United States

Collaborators and Investigators

Sponsor: Ardelyx

David Rosenbaum, PhD, STUDY_DIRECTOR, 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 Date2024-07-24

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-07-24

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

IBS-C

Additional Relevant MeSH Terms

Irritable Bowel Syndrome With Constipation (IBS-C)