F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

• ClinicalTrials.gov Identifier: NCT00857272
• Recruitment Status: Completed
• First Posted: March 6, 2009
• Results First Posted: September 28, 2010
• Last Update Posted: October 5, 2010
• Sponsor: Braintree Laboratories
• Information provided by: Braintree Laboratories

Study Description

Brief Summary:

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Condition or disease	Intervention/treatment	Phase
Colonoscopy	Drug: PEG electrolyte lavage solution + bisacodyl - reformulation; Drug: PEG electrolyte lavage solution + bisacodyl	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 308 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
• Study Start Date: February 2009
• Actual Primary Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: HalfLytely with 10mg bisacodyl; Active control	Drug: PEG electrolyte lavage solution + bisacodyl; multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
Experimental: HalfLytely with 5mg bisacodyl; Investigational dose	Drug: PEG electrolyte lavage solution + bisacodyl - reformulation; multi dose formulation (tablet/solution) for oral administration prior to colonoscopy

Outcome Measures

Primary Outcome Measures :

1. Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale [ Time Frame: during colonoscopy ]
   Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
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, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration
3. Subjects who are undergoing colonoscopy for foreign body removal and decompression
4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
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 who are 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 clinical, surgical, drug, or device study within the past 30 days

Contacts and Locations

Locations

United States, California

Advanced Clinical Research Institute

Anaheim, California, United States, 92801

Advanced Clinical Research Institute

Orange, California, United States, 92869

Medical Associates Research Group

San Diego, California, United States, 92123

United States, Florida

United Medical Research

New Smyrna Beach, Florida, United States, 32168

United States, Maryland

Maryland Digestive Disease Research

Laurel, Maryland, United States, 20707

United States, Tennessee

Franklin Gastroenterology

Franklin, Tennessee, United States, 37067

Sponsors and Collaborators

Braintree Laboratories

Investigators

• Study Director: John McGowan, MPH; Braintree Laboratories, Inc.

More Information

• Responsible Party: John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT00857272
• Other Study ID Numbers: F38-27
• First Posted: March 6, 2009
• Results First Posted: September 28, 2010
• Last Update Posted: October 5, 2010
• Last Verified: September 2010

Keywords provided by Braintree Laboratories:

colonoscopy; bowel preparation

Additional relevant MeSH terms:

Bisacodyl; Pharmaceutical Solutions; Cathartics; Gastrointestinal Agents; Laxatives