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

Exclusion Criteria33

• 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