An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects - Full Text View

Sponsored by:	Braintree Laboratories
Information provided by:	Braintree Laboratories
ClinicalTrials.gov Identifier:	NCT00278967

Purpose

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

Condition	Intervention	Phase
Colonoscopy	Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit Drug: HalfLytely - Reformulation	Phase IV

MedlinePlus related topics: Colonoscopy

Drug Information available for: Bisacodyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:

Efficacy - preparation quality using a 4-point scale

Secondary Outcome Measures:

Safety - patient-reported preparation related side-effects

Estimated Enrollment:	450
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278967

Locations

United States, California

Anaheim, California, United States, 92801
United States, Florida

Miami, Florida, United States, 33173

Jupiter, Florida, United States, 33458
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

Spokane, Washington, United States, 99207

Bellevue, Washington, United States, 98004

Sponsors and Collaborators

Braintree Laboratories

Investigators

Principal Investigator:

Michael Goldstein, M.D.

Long Island GI Research Group

More Information

No publications provided

Study ID Numbers:	F38-26
Study First Received:	January 13, 2006
Last Updated:	October 18, 2006
ClinicalTrials.gov Identifier:	NCT00278967 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:

colonoscopy
preparation

Study placed in the following topic categories:

Bisacodyl

ClinicalTrials.gov processed this record on May 07, 2009