Clinical trial NCT01501513: A Safety Study of 3 Different Bowel Cleansing Preparations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Bowel Preparation
Endoscopy
Keywords: colonoscopy
bowel preparation
endoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2011-12-29
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With Successful Bowel Preparation
timeFrame: Day of colonoscopy
Secondary outcomes:
measure: Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy
timeFrame: 2 days
measure: Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7
timeFrame: 7 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Portland
country: United States
facility: Northwest Gastroenterology
state: Oregon
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Franklin
country: United States
facility: Franklin Gastroenterology
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
References: