A Safety Study of 3 Different Bowel Cleansing Preparations

NCT01501513 | Completed Phase 3 Results

• 1 other identifier: BLI800-440
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 17

Brief Summary

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Conditions

Colonoscopy; Bowel Preparation; Endoscopy

Keywords

colonoscopy; bowel preparation; endoscopy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Successful Bowel Preparation

  Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).

  Day of colonoscopy

Secondary Outcomes (2)

• Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy

  2 days

• Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7

  7 days

Study Arms (3)

BLI800 approved preparation regimen

EXPERIMENTAL

BLI800 approved preparation regimen

Drug: BLI800 approved preparation regimen

BLI800 investigational preparation regimen

EXPERIMENTAL

BLI800 investigational preparation regimen

Drug: BLI800 investigational preparation regimen

PEG-3350 based bowel preparation

ACTIVE COMPARATOR

PEG-3350 based bowel preparation

Drug: PEG-3350 based bowel preparation

Interventions

PEG-3350 based bowel preparation DRUG

solution for oral administration prior to colonoscopy

PEG-3350 based bowel preparation

BLI800 approved preparation regimen DRUG

solution for oral administration prior to colonoscopy

BLI800 approved preparation regimen

BLI800 investigational preparation regimen DRUG

solution for oral administration prior to colonoscopy

BLI800 investigational preparation regimen

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
• 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 significant gastrointestinal surgeries.
• Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
• Subjects with severe liver or renal insufficiency.
• Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
• 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 (17)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States

Location

Gastrointestinal Associates

Jackson, Mississippi, 39202, United States

Location

Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States

Location

Carolina Digestive Health Associates

Charlotte, North Carolina, 28262, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Northwest Gastroenterology

Portland, Oregon, 97210, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Franklin Gastroenterology

Franklin, Tennessee, 37067, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Results Point of Contact

• Title: Head of R&D, GI
• Organization: Braintree Laboratories, Inc.

studydirector@sebelapharma.com

781-843-2202

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: March 4, 2013
• Study Completion: March 4, 2013
• Last Updated: January 17, 2024
• Results First Posted: January 17, 2024

Record last verified: 2023-12

Locations

US (17)