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

Description

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.

Study Start Date

January, 11 2018

Estimated Completion Date

December 2018

Interventions

  • Drug: BLI4700
  • Drug: FDA Approved Bowel Preparation

Study ID

Braintree Laboratories -- BLI4700-301

Status

Unknown

Trial ID

NCT03404401

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

575

Sponsor

Braintree Laboratories

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.

Gender

All

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (23)

Study Location Distance Name Phone Email
Braintree Research Site 210 - Great Neck, New York 38.6 miles None None None
Braintree Research Site 207 - Hagerstown, Maryland 258.7 miles None None None
Braintree Research Site 214 - Cincinnati, Ohio 613.2 miles None None None
Braintree Research Site 216 - Columbia, South Carolina 651.8 miles None None None
Braintree Research Site 208 - Milwaukee, Wisconsin 764.1 miles None None None
Braintree Research Site 215 - Decatur, Georgia 792.8 miles None None None
Braintree Research Site 224 - Atlanta, Georgia 793.5 miles None None None
Braintree Research Site 202 - Franklin, Tennessee 819.3 miles None None None
Braintree Research Site 222 - Jacksonville, Florida 889.9 miles None None None
Braintree Research Site 203 - Jackson, Tennessee 926.0 miles None None None
Braintree Research Site 221 - Inverness, Florida 1,004.5 miles None None None
Braintree Research Site 201 - Palm Harbor, Florida 1,056.8 miles None None None
Braintree Research Site 212 - Mobile, Alabama 1,107.7 miles None None None
Braintree Research Site 218 - Flowood, Mississippi 1,121.9 miles None None None
Braintree Research Site 211 - Monroe, Louisiana 1,202.2 miles None None None
Braintree Research Site 223 - Lake Charles, Louisiana 1,350.4 miles None None None
Braintree Research Site 217 - Ogden, Utah 2,001.1 miles None None None
Braintree Research Site 204 - Tucson, Arizona 2,161.1 miles None None None
Braintree Research Site 220 - San Diego, California 2,467.6 miles None None None
Braintree Research Site 219 - Chula Vista, California 2,468.3 miles None None None
Braintree Research Site 213 - Portland, Oregon 2,468.8 miles None None None
Braintree Research Site 209 - Anaheim, California 2,480.1 miles None None None
Braintree Research Site 206 - Los Angeles, California 2,500.0 miles None None None

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