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

Braintree Laboratories0 sites450 target enrollmentFebruary 2006

ConditionsColonoscopy

DrugsHalfLytely with Bisacodyl Tablets Bowel Prep Kit HalfLytely - Reformulation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Colonoscopy
Sponsor: Braintree Laboratories
Enrollment: 450
Primary Endpoint: Efficacy - preparation quality using a 4-point scale
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

August 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Braintree Laboratories

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