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

Braintree Laboratories

Status and phase

Completed

Phase 4

Conditions

Colonoscopy

Treatments

Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit

Drug: HalfLytely - Reformulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00278967

F38-26

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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