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
sites
901 Sumter Street
Columbia, South Carolina 29203
2322
mi
from 98109
Columbia, SC
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Anaheim, California 92801
980
mi
from 98109
Anaheim, CA
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Atlanta, Georgia 30328
2171
mi
from 98109
Atlanta, GA
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Chula Vista, California 91910
1072
mi
from 98109
Chula Vista, CA
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Cincinnati, Ohio 45224
1967
mi
from 98109
Cincinnati, OH
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215 North Decatur Lane
Decatur, Georgia 30033
2182
mi
from 98109
Decatur, GA
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Flowood, Mississippi 39232
1985
mi
from 98109
Flowood, MS
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Franklin, Tennessee 37067
1981
mi
from 98109
Franklin, TN
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Great Neck, New York 11023
2411
mi
from 98109
Great Neck, NY
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1100 Dual Highway
Hagerstown, Maryland 21742
2266
mi
from 98109
Hagerstown, MD
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Inverness, Florida 34452
2492
mi
from 98109
Inverness, FL
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1938 Emporium Drive
Jackson, Tennessee 38305
1896
mi
from 98109
Jackson, TN
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Jacksonville, Florida 32207
2452
mi
from 98109
Jacksonville, FL
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Lake Charles, Louisiana 70601
1953
mi
from 98109
Lake Charles, LA
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Los Angeles, California 90045
967
mi
from 98109
Los Angeles, CA
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Milwaukee, Wisconsin 53226
1687
mi
from 98109
Milwaukee, WI
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Mobile, Alabama 36688
2146
mi
from 98109
Mobile, AL
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Monroe, Louisiana 71201
1890
mi
from 98109
Monroe, LA
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5896 South Ridgeline Drive
Ogden, Utah 84405
680
mi
from 98109
Ogden, UT
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31400 US Highway 19 North
Palm Harbor, Florida 34684
2509
mi
from 98109
Palm Harbor, FL
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Portland, Oregon 97210
145
mi
from 98109
Portland, OR
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220 Dickinson Street
San Diego, California 92114
1063
mi
from 98109
San Diego, CA
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Tucson, Arizona 85724
1221
mi
from 98109
Tucson, AZ
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