Status:
RECRUITING
4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
Lead Sponsor:
Ardelyx
Conditions:
Irritable Bowel Syndrome with Constipation (IBS-C)
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be gi...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
- History of non-retentive fecal incontinence;
- Required manual disimpaction any time prior to randomization (after consent)
- 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.
- 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
- 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
Key Trial Info
Start Date :
July 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06553547
Start Date
July 24 2024
End Date
June 1 2026
Last Update
January 17 2025
Active Locations (2)
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1
Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, United States, 33143
2
Texas Digestive Specialists
Harlingen, Texas, United States, 78550