Full Text View
Tabular View
No Study Results Posted
Related Studies
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
This study is ongoing, but not recruiting participants.
First Received: March 5, 2009   Last Updated: April 17, 2009   History of Changes
Sponsored by: Braintree Laboratories
Information provided by: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00856843
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: BLI800
Drug: Polyethylene glycol 3350 based bowel preparation
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Efficacy: preparation success based on a 4 point scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: preparation related side effects, blood chemistry [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
Polyethylene glycol 3350 based bowel preparation
Drug: Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy
1: Experimental
BLI800
Drug: BLI800
Solution for oral administration prior to colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
  2. At least 18 years of age
  3. Otherwise in good health, as determined by physical exam and medical history
  4. If female, and of child-bearing potential, is using an acceptable form of birth control
  5. Negative urine pregnancy test at screening, if applicable
  6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

  1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  2. Subjects who had previous gastrointestinal surgeries.
  3. 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.
  4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
  5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  6. Subjects undergoing colonoscopy for foreign body removal and decompression.
  7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  8. Subjects of childbearing potential who refuse a pregnancy test.
  9. Subjects allergic to any preparation components
  10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
  11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856843

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Florida
Jupiter Research
Jupiter, Florida, United States, 33458
Miami Research Associates
Miami, Florida, United States, 33143
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, New York
Long Island GI Research Group
Great Neck, New York, United States, 11023
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan, BS Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Mgr. )
Study ID Numbers: BLI800-303
Study First Received: March 5, 2009
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00856843     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation

ClinicalTrials.gov processed this record on September 10, 2009