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This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI-800 | Drug | |||
| Polyethylene glycol 3350 based bowel preparation | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - preparation quality using a 4 point scale | 2-Day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - preparation related side effects; laboratory analysis | 30-Day |
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Inclusion Criteria:
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
At least 18 years of age
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, abstinent, or vasectomized spouse)
Negative urine pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D McGowan, BS | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36693 | United States | |||
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Jupiter | Florida | 33458 | United States |
| Miami | Florida | 33143 | United States |
| New Smyrna Beach | Florida | 32168 | United States |
| Monroe | Louisiana | 71201 | United States |
| Laurel | Maryland | 20707 | United States |
| Great Neck | New York | 11023 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Lancaster | Pennsylvania | 17604 | United States |
| Chesapeake | Virginia | 23320 | United States |