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

Study Description

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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: HalfLytely with Bisacodyl Tablets Bowel Prep Kit; Drug: HalfLytely - Reformulation	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	450 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Treatment
Official Title:	An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study Start Date :	February 2006
Study Completion Date :	August 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Efficacy - preparation quality using a 4-point scale

Secondary Outcome Measures :

1. Safety - patient-reported preparation related side-effects

Eligibility Criteria

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

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

Contacts and Locations

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Locations

United States, California
Anaheim, California, United States, 92801
United States, Florida
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33173
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Laurel, Maryland, United States, 20707
United States, New York
Great Neck, New York, United States, 11023
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Washington
Bellevue, Washington, United States, 98004
Spokane, Washington, United States, 99207

Sponsors and Collaborators

Braintree Laboratories

Investigators

Principal Investigator:	Michael Goldstein, M.D.	Long Island GI Research Group

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00278967 History of Changes
Other Study ID Numbers:	F38-26
First Posted:	January 19, 2006
Last Update Posted:	October 19, 2006
Last Verified:	October 2006

Keywords provided by Braintree Laboratories:

colonoscopy; preparation

Additional relevant MeSH terms:

Bisacodyl; Cathartics; Gastrointestinal Agents; Laxatives