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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404401
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: BLI4700 Drug: Polyethylene glycol bowel preparation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: BLI4700 Bowel Preparation Drug: BLI4700
Oral bowel preparation

Active Comparator: FDA Approved Bowel Preparation Drug: Polyethylene glycol bowel preparation
Oral bowel preparation




Primary Outcome Measures :
  1. % of subjects with successful bowel preparation [ Time Frame: Day of colonoscopy ]
    % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404401


Locations
Show Show 23 study locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Study Director: John McGowan, MPH Braintree Laboratories, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT03404401    
Other Study ID Numbers: BLI4700-301
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No