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An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
This study has been completed.
Study NCT00278967   Information provided by Braintree Laboratories
First Received: January 13, 2006   Last Updated: October 18, 2006   History of Changes

January 13, 2006
October 18, 2006
February 2006
 
Efficacy - preparation quality using a 4-point scale
Same as current
Complete list of historical versions of study NCT00278967 on ClinicalTrials.gov Archive Site
Safety - patient-reported preparation related side-effects
Same as current
 
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.

Phase IV
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Colonoscopy
  • Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit
  • Drug: HalfLytely - Reformulation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
450
August 2006
 

Inclusion Criteria:

- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

  • At least 18 years of age
  • 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, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator’s judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration
  • Subjects who are undergoing colonoscopy for foreign body removal and decompression
  • 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 taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
  • Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any preparation components
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00278967
 
F38-26
Braintree Laboratories
 
Principal Investigator: Michael Goldstein, M.D. Long Island GI Research Group
Braintree Laboratories
October 2006

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