An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
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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: NCT00278967 |
Recruitment Status :
Completed
First Posted : January 19, 2006
Last Update Posted : October 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colonoscopy | Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit Drug: HalfLytely - Reformulation | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects |
Study Start Date : | February 2006 |
Study Completion Date : | August 2006 |

- Efficacy - preparation quality using a 4-point scale
- Safety - patient-reported preparation related side-effects

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00278967
United States, California | |
Anaheim, California, United States, 92801 | |
United States, Florida | |
Jupiter, Florida, United States, 33458 | |
Miami, Florida, United States, 33173 | |
United States, Louisiana | |
Baton Rouge, Louisiana, United States, 70809 | |
United States, Maryland | |
Laurel, Maryland, United States, 20707 | |
United States, New York | |
Great Neck, New York, United States, 11023 | |
United States, North Carolina | |
Raleigh, North Carolina, United States, 27612 | |
United States, Tennessee | |
Germantown, Tennessee, United States, 38138 | |
United States, Washington | |
Bellevue, Washington, United States, 98004 | |
Spokane, Washington, United States, 99207 |
Principal Investigator: | Michael Goldstein, M.D. | Long Island GI Research Group |
ClinicalTrials.gov Identifier: | NCT00278967 |
Other Study ID Numbers: |
F38-26 |
First Posted: | January 19, 2006 Key Record Dates |
Last Update Posted: | October 19, 2006 |
Last Verified: | October 2006 |
colonoscopy preparation |
Bisacodyl Cathartics Gastrointestinal Agents Laxatives |