BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/30/2018 |
Start Date: | February 16, 2017 |
End Date: | April 10, 2017 |
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel
preparation prior to colonoscopy in adult patients.
preparation prior to colonoscopy in adult patients.
Primary Inclusion Criteria:
1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
indication.
2. At least 18 years of age
3. If female, and of child-bearing potential, is using an acceptable form of birth
control.
4. Negative urine pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed
consent to participate in the study
Primary Exclusion Criteria:
1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the
study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study
for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study
within the past 30 days.
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