A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy.

Condition(s) targeted: Colonoscopy

Intervention: HalfLytely (Drug); Visicol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Braintree Laboratories

Official(s) and/or principal investigator(s):
Charles Brady, MD, Principal Investigator, Affiliation: University of Texas Health Science Center San Antonio

The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.

Official title: A Comparison of the Efficacy and Safety of Two Bowel Preparations: HalfLytely® (2L NuLYTELY and 20 Mg Bisacodyl), and Visicol™ Prior To Colonoscopy.

Study design: Randomized, Single Blind, Active Control, Factorial Assignment

Primary outcome: Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.

Secondary outcome:

Safety: review of preparation symptoms, adverse events and laboratory testing.

Patient acceptance

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female outpatients who are undergoing colonoscopy for routinely accepted

indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).

- 18 years of age or older.

- 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, or vasectomized spouse).

- Subjects with electrolyte abnormalities such as hypernatremia, hyperphosphatemia,

hypokalemia, or hypocalcemia must have them corrected prior to study participation.

- Subject has read and signed the written informed consent document prior to study

participation.

Exclusion Criteria:

- Subjects with known or suspected bowel perforation or obstruction, severe inflammatory

bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon, or massive and/or abnormal rectal bleeding.

- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

- Subjects with uncontrolled cardiovascular disease.

- Subjects with congestive heart failure.

- Subjects with unstable angina pectoris.

- Subjects with ascites.

- Subjects with renal insufficiency.

- 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.

- Subjects who are pregnant or lactating.

- Subjects who are allergic to polyethyleneglycol.

- Subjects who are allergic to sodium phosphate salts.

- Subjects who are currently taking, or plan to take, other sodium phosphate- containing

products, such as enemas or non-prescription liquid purgatives.

- 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 receiving non-study laxatives, antacids and prokinetic agents during the

study.

San Antonio, Texas 78284, United States

Starting date: June 2001
Last updated: September 9, 2005