An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Information source: Braintree Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Intervention: HalfLytely with Bisacodyl Tablets Bowel Prep Kit (Drug); HalfLytely - Reformulation (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Braintree Laboratories Official(s) and/or principal investigator(s):
Michael Goldstein, M.D., Principal Investigator, Affiliation: Long Island GI Research Group
Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to
colonoscopy in adult subjects.
Clinical Details
Official title: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy - preparation quality using a 4-point scale
Secondary outcome: Safety - patient-reported preparation related side-effects
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Anaheim, California 92801, United States
Miami, Florida 33173, United States
Jupiter, Florida 33458, United States
Baton Rouge, Louisiana 70809, United States
Laurel, Maryland 20707, United States
Great Neck, New York 11023, United States
Raleigh, North Carolina 27612, United States
Germantown, Tennessee 38138, United States
Spokane, Washington 99207, United States
Bellevue, Washington 98004, United States
Additional Information
Starting date: February 2006
Ending date: August 2006
Last updated: October 18, 2006
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