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

Launched by ARDELYX · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called tenapanor for young people aged 12 to under 18 years who have Irritable Bowel Syndrome with Constipation (IBS-C). The main goal is to see if tenapanor is safe and effective in helping these patients over a period of 12 weeks. Participants will take the medication twice a day and will be randomly assigned to receive either the medication or a placebo (a non-active pill) without knowing which one they’re getting.

To be eligible for the trial, participants need to be within the specified age range, weigh at least 18 kg, and meet certain criteria for IBS-C. For example, they should be willing to stop using laxatives during the study and have their parents or guardians provide consent. Throughout the trial, participants will be asked to keep track of their symptoms using an electronic diary. It’s important to note that some health issues, like certain gastrointestinal diseases or significant past surgeries, may exclude someone from participating. This study aims to improve treatment options for IBS-C in children and teens, so their involvement could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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

Trial Officials