BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Colonoscopy Clinical Trial

Official title:

BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786629
• Other study ID #: BLI800-480
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: August 6, 2014
• Start date: December 2012

Study information

• Verified date: August 2014
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

At least 18 years of age

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

Exclusion Criteria:

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

Subjects who had previous significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency

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 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.

Subjects who withdraw consent before completion of Visit 1 procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Endoscopy

Intervention

Drug:
• SUPREP Bowel Prep Kit
solution for oral administration prior to colonoscopy
• FDA approved bowel preparation containing electrolytes
solution for oral administration prior to colonoscopy

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Franklin Gastroenterology	Franklin	Tennessee
United States	Long Island GI Research Group	Great Neck	New York
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Gastrointestinal Associates	Jackson	Mississippi
United States	University of South Alabama	Mobile	Alabama
United States	Northwest Gastroenterology Clinic	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")		Day of colonoscopy	No