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

Ki vehet részt

• ≥6 and <12 years old at the Screening visit (Visit 1)
• 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
• Meet the Modified Diagnostic 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)
• Meet 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 verbal assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Ki nem vehet részt

• Required manual disimpaction any time prior to randomization (after consent)
• 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:; 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
• Participation in other clinical trials within 1 month prior to Screening
• History of non-retentive fecal incontinence
• 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
• Patient has any of the following conditions:; Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy; Cystic fibrosis; 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; Down's syndrome or any other chromosomal disorder; Active anal fissure (Note: History of anal fissure is not an exclusion); Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus); Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies); Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma); Lead toxicity, hypercalcemia; Neurodevelopmental disabilities; 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 and could confound the assessments in this study; History of cancer other than treated basal cell carcinoma of the skin; History of diabetic neuropathy
• History of alcohol or substance abuse
• 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
• Functional diarrhea as defined by Modified Rome IV child/adolescent criteria
• IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Modified Rome IV child/adolescent criteria
• 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