Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT02189850
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female between the ages of 12 to 17
* Weight more than 40kg
* Undergoing colonoscopy for routinely accepted indications
* If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
* Negative pregnancy test at screening, if applicable
* In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.
Exclusion Criteria:
* Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results
* Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
* Subjects with a prior history of renal, liver or cardiac insufficiency
* Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
* Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02189850
Study Brief:
Protocol Section:
NCT02189850