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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164151
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 7, 2013
Information provided by:
Braintree Laboratories

September 9, 2005
September 14, 2005
February 7, 2013
June 2001
May 2002   (Final data collection date for primary outcome measure)
Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.
Same as current
Complete list of historical versions of study NCT00164151 on Archive Site
  • Safety: review of preparation symptoms, adverse events and laboratory testing.
  • Patient acceptance
Same as current
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A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy.
A Comparison of the Efficacy and Safety of Two Bowel Preparations: HalfLytely® (2L NuLYTELY and 20 mg Bisacodyl), and Visicol™ Prior To Colonoscopy.
The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.
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Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
  • Drug: HalfLytely
  • Drug: Visicol
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2002   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
United States
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Braintree Laboratories
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Principal Investigator: Charles Brady, MD University of Texas Health Science Center San Antonio
Braintree Laboratories
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP