An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
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| ClinicalTrials.gov Identifier: NCT00278967 |
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Recruitment Status :
Completed
First Posted : January 19, 2006
Last Update Posted : October 19, 2006
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Sponsor:
Braintree Laboratories
Information provided by:
Braintree Laboratories
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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 |
|---|---|---|
| Colonoscopy | Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit Drug: HalfLytely - Reformulation | Phase 4 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colonoscopy
Drug Information available for:
Bisacodyl
Primary Outcome Measures :
- Efficacy - preparation quality using a 4-point scale
Secondary Outcome Measures :
- 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 |
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
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): NCT00278967
Locations
| 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 | |
Sponsors and Collaborators
Braintree Laboratories
Investigators
| Principal Investigator: | Michael Goldstein, M.D. | Long Island GI Research Group |
| ClinicalTrials.gov Identifier: | NCT00278967 History of Changes |
| Other Study ID Numbers: |
F38-26 |
| First Posted: | January 19, 2006 Key Record Dates |
| Last Update Posted: | October 19, 2006 |
| Last Verified: | October 2006 |
Keywords provided by Braintree Laboratories:
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colonoscopy preparation |
Additional relevant MeSH terms:
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Bisacodyl Cathartics Gastrointestinal Agents Laxatives |