A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:9/29/2018
Start Date:January 11, 2018
End Date:July 10, 2018

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BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

The objective of this study is to compare the safety and efficacy of BLI4700 bowel
preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations
prior to colonoscopy in adult patients.


Inclusion Criteria:

- Male or female outpatients who are undergoing colonoscopy for a routinely accepted
indication.

- 18 to 85 years of age (inclusive)

- If female, and of child-bearing potential, is using an acceptable form of birth
control

- Negative serum 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:

- Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis,
gastric retention, bowel perforation, toxic colitis or megacolon.

- Subjects with ongoing severe, acute inflammatory bowel disease

- Subjects who had previous significant gastrointestinal surgeries.

- Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with
clinically significant electrolyte abnormalities based on Visit 1 laboratory results.

- Subjects taking diuretics, anti-hypertensive medications, including angiotensin
converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or
chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain
is not exclusionary.

- Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or
diastolic blood pressure > 100 mmHg).

- Subjects taking antibiotics within 7 days of colonoscopy.

- Subjects with severe renal insufficiency (GFR < 30 mL/min/1.73m2).

- Subjects with known severe hepatic insufficiency (Child Pugh C)

- Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).

- Subjects with an abnormal and clinically significant physical examination or ECG
finding at Visit 1.

- Subjects undergoing insulin therapy for any indication.

- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

- Subjects undergoing colonoscopy for foreign body removal and/or decompression.

- Subjects who are pregnant or lactating, or intending to become pregnant during the
study.

- Subjects of childbearing potential who refuse a pregnancy test.

- Subjects allergic to any preparation component.

- Subjects using drugs of abuse, including abused prescription medications.

- Subjects who are withdrawing from alcohol or benzodiazepines.

- 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 surgical, drug, or device study
within the past 30 days.
We found this trial at
23
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Anaheim, California 92801
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Atlanta, Georgia 30328
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Chula Vista, California 91910
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Cincinnati, Ohio 45224
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901 Sumter Street
Columbia, South Carolina 29203
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215 North Decatur Lane
Decatur, Georgia 30033
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Decatur, GA
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Flowood, Mississippi 39232
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Franklin, Tennessee 37067
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Franklin, TN
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Great Neck, New York 11023
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Great Neck, NY
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1100 Dual Highway
Hagerstown, Maryland 21742
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Inverness, Florida 34452
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1938 Emporium Drive
Jackson, Tennessee 38305
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Jacksonville, Florida 32207
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Lake Charles, Louisiana 70601
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Los Angeles, California 90045
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Mobile, Alabama 36688
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Mobile, AL
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Monroe, Louisiana 71201
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5896 South Ridgeline Drive
Ogden, Utah 84405
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31400 US Highway 19 North
Palm Harbor, Florida 34684
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Portland, Oregon 97210
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Portland, OR
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220 Dickinson Street
San Diego, California 92114
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Tucson, Arizona 85724
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Tucson, AZ
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