An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

NCT ID: NCT00278967

Last Updated: 2006-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-08-31

Brief Summary

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

Detailed Description

The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.

Conditions

Colonoscopy

Keywords

colonoscopy; preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

HalfLytely with Bisacodyl Tablets Bowel Prep Kit

Intervention Type: DRUG

HalfLytely - Reformulation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

• At least 18 years of age
• Otherwise in good health, as determined by physical exam and medical history
• If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
• 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, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration
• Subjects who are undergoing colonoscopy for foreign body removal and decompression
• Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
• Subjects who are taking drugs that may affect electrolyte levels
• Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
• Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
• Subjects who are pregnant or lactating, or intending to become pregnant during the study
• Subjects of childbearing potential who refuse a pregnancy test
• Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael Goldstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Long Island GI Research Group

Locations

Anaheim, California, United States

Jupiter, Florida, United States

Miami, Florida, United States

Baton Rouge, Louisiana, United States

Laurel, Maryland, United States

Great Neck, New York, United States

Raleigh, North Carolina, United States

Germantown, Tennessee, United States

Bellevue, Washington, United States

Spokane, Washington, United States

Countries

United States

Other Identifiers

F38-26

Identifier Type: -

Identifier Source: org_study_id