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

• ClinicalTrials.gov Identifier: NCT00278967
• Recruitment Status: Completed
• First Posted: January 19, 2006
• Last Update Posted: October 19, 2006
• 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: 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

• 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

Outcome Measures

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

• ClinicalTrials.gov Identifier: NCT00278967
• 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