An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study Details
Study Description
Brief Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy - preparation quality using a 4-point scale []
Secondary Outcome Measures
- Safety - patient-reported preparation related side-effects []
Eligibility Criteria
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
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At least 18 years of age
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Otherwise in good health, as determined by physical exam and medical history
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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)
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Negative urine pregnancy test at screening, if applicable
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In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria:
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Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
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Subjects with impaired consciousness that predisposes them to pulmonary aspiration
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Subjects who are undergoing colonoscopy for foreign body removal and decompression
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Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
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Subjects who are taking drugs that may affect electrolyte levels
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Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
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Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
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Subjects who are pregnant or lactating, or intending to become pregnant during the study
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Subjects of childbearing potential who refuse a pregnancy test
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Subjects who are allergic to any preparation components
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Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
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Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim | California | United States | 92801 | |
| 2 | Jupiter | Florida | United States | 33458 | |
| 3 | Miami | Florida | United States | 33173 | |
| 4 | Baton Rouge | Louisiana | United States | 70809 | |
| 5 | Laurel | Maryland | United States | 20707 | |
| 6 | Great Neck | New York | United States | 11023 | |
| 7 | Raleigh | North Carolina | United States | 27612 | |
| 8 | Germantown | Tennessee | United States | 38138 | |
| 9 | Bellevue | Washington | United States | 98004 | |
| 10 | Spokane | Washington | United States | 99207 |
Sponsors and Collaborators
- Braintree Laboratories
Investigators
- Principal Investigator: Michael Goldstein, M.D., Long Island GI Research Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F38-26