BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

NCT00856843 | Completed Phase 3 Results

• 1 other identifier: BLI800-303
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Conditions

Colonoscopy

Keywords

colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale

  Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.

  2 days

Secondary Outcomes (13)

• Assessment of Residual Stool - Cecum

  2 days

• Assessment of Residual Stool - Ascending Colon

  2 days

• Assessment of Residual Stool - Transverse Colon

  2 days

• Assessment of Residual Stool - Descending Colon

  2 days

• Assessment of Residual Stool - Sigmoid Colon/Rectum

  2 days

Study Arms (2)

Polyethylene glycol 3350 based bowel preparation

ACTIVE COMPARATOR

Polyethylene glycol 3350 based bowel preparation

Drug: Polyethylene glycol 3350 based bowel preparation

BLI800

EXPERIMENTAL

BLI800

Drug: BLI800

Interventions

BLI800 DRUG

Solution for oral administration prior to colonoscopy

BLI800

Polyethylene glycol 3350 based bowel preparation DRUG

Solution for oral administration prior to colonoscopy

Polyethylene glycol 3350 based bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
• Subjects who had previous gastrointestinal surgeries.
• Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
• Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects undergoing colonoscopy for foreign body removal and 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 components
• 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (5)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Jupiter Research

Jupiter, Florida, 33458, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Long Island GI Research Group

Great Neck, New York, 11023, United States

Location

Related Publications (1)

• Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.

  PMID: 20646695 DERIVED

Limitations and Caveats

As prespecified in the study protocol, expected prep related side effects (nausea, vomiting, cramping, bloating and overall discomfort) were only documented as AEs if patients rated them severely distressing on the study questionnaire.

Results Point of Contact

• Title: John McGowan
• Organization: Braintree Laboratories, Inc.

jmcgowan@braintreelabs.com

781-843-2202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Last Updated: November 10, 2010
• Results First Posted: November 10, 2010

Record last verified: 2010-10

Locations

US (5)