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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00164151
First received: September 9, 2005
Last updated: February 6, 2013
Last verified: February 2013

September 9, 2005
February 6, 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 ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Colonoscopy
  • Drug: HalfLytely
  • Drug: Visicol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
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.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164151
F38-23
Not Provided
Not Provided
Braintree Laboratories
Not Provided
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