A Safety Study of 3 Different Bowel Cleansing Preparations

Colonoscopy Clinical Trial

Official title:

A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501513
• Other study ID #: BLI800-440
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: March 4, 2013

Study information

• Verified date: December 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: March 4, 2013
• Est. primary completion date: March 4, 2013
• Accepts healthy volunteers: No
• Gender: All
• 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 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.

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Endoscopy

Intervention

Drug:
• PEG-3350 based bowel preparation
solution for oral administration prior to colonoscopy
• BLI800 approved preparation regimen
solution for oral administration prior to colonoscopy
• BLI800 investigational preparation regimen
solution for oral administration prior to colonoscopy

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	ClinSearch	Chattanooga	Tennessee
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Franklin Gastroenterology	Franklin	Tennessee
United States	Indiana University	Indianapolis	Indiana
United States	Gastrointestinal Associates	Jackson	Mississippi
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of South Alabama	Mobile	Alabama
United States	Delta Research Partners	Monroe	Louisiana
United States	Northwest Gastroenterology	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Miami Research Associates	South Miami	Florida

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 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	Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy	Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).	2 days
Secondary	Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7	Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).	7 days