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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.
 
ClinicalTrials.gov Identifier: NCT00164151
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 7, 2013
Sponsor:
Information provided by:
Braintree Laboratories

Brief 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: HalfLytely Drug: Visicol Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
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 Start Date : June 2001
Actual Primary Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Visicol




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

Secondary Outcome Measures :
  1. Safety: review of preparation symptoms, adverse events and laboratory testing.
  2. Patient acceptance


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164151


Locations
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United States, Texas
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Principal Investigator: Charles Brady, MD University of Texas Health Science Center San Antonio
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ClinicalTrials.gov Identifier: NCT00164151    
Other Study ID Numbers: F38-23
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Braintree Laboratories:
colonoscopy preparation
prep