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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00425594
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
* Evaluation of BE results
* Endosonography
* Blood in stool
* Anemia of unknown etiology
* Abdominal Pain
* Polypectomy
* Unknown diarrhea or constipation etiology
* Inflammatory bowel disease
* Between 6 and 16 years of age at screening.
* Otherwise in good health, as determined by physical exam and medical history.
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse).
* Negative urine pregnancy test at screening, if applicable
* In the investigator's judgment, parent/guardian is mentally competent to provide informed consent to participate in the study.
Exclusion Criteria:
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
* Subjects impacted at screening
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with known difficulties for swallowing tablets
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics.
* Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics.
* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days.
* Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT00425594
Study Brief:
Protocol Section:
NCT00425594