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

Last updated: February 6, 2013
Sponsor: Braintree Laboratories
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT00164151
F38-23
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female outpatients who are undergoing colonoscopy for routinely acceptedindications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology,Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except asnoted below), Unknown diarrhea etiology, Polypectomy, Laser therapy, Foreign bodyremoval 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 birthcontrol (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 studyparticipation.

Exclusion

Exclusion Criteria:

  • Subjects with known or suspected bowel perforation or obstruction, severe inflammatorybowel disease, ileus, acute alimentary tract surgery, significant gastroparesis orgastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxicmegacolon, 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 studyfor any reason, including inability to follow study procedures.

  • Subjects who have participated in an investigational clinical, surgical, drug, ordevice 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- containingproducts, such as enemas or non-prescription liquid purgatives.

  • Subjects with pre-existing electrolyte disturbances, such as dehydration, or thosesecondary 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 thestudy.

Study Design

Total Participants: 60
Study Start date:
June 01, 2001
Estimated Completion Date:

Connect with a study center

  • San Antonio, Texas 78284
    United States

    Site Not Available

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