Full Text View
Tabular View
No Study Results Posted
Related Studies
A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy.
This study has been completed.
Study NCT00164151   Information provided by Braintree Laboratories
First Received: September 9, 2005   No Changes Posted

September 9, 2005
September 9, 2005
June 2001
 
Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.
Same as current
No Changes Posted
  • Safety: review of preparation symptoms, adverse events and laboratory testing.
  • Patient acceptance
Same as current
 
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.

 
Phase III
Interventional
Randomized, Single Blind, Active Control, Factorial Assignment
Colonoscopy
  • Drug: HalfLytely
  • Drug: Visicol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

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
 
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164151
 
F38-23
Braintree Laboratories
 
Principal Investigator: Charles Brady, MD University of Texas Health Science Center San Antonio
Braintree Laboratories
September 2005

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