Efficacy of Lubiprostone in Combination With Standard PEG Preparation
Tracking Information | |||||
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First Received Date ICMJE | May 29, 2008 | ||||
Last Updated Date | July 19, 2011 | ||||
Start Date ICMJE | May 2008 | ||||
Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary measured endpoint will be the quality of colonoscopy preparations as rated by blinded colonoscopists by a 5-point Likert Scale, and compared using the chi-square statistics. [ Time Frame: End of study ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00689026 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy of Lubiprostone in Combination With Standard PEG Preparation | ||||
Official Title ICMJE | Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial | ||||
Brief Summary | A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics. |
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Detailed Description | STUDY DESIGN This is an investigator-initiated, single site (MCG only), single-blinded prospective study comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4L PEG alone on preparation quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who require a colonoscopy will be randomized to one of the two groups of 60 (total of 120 patients): Control Group: All patients in the study will receive a standard oral 4L PEG colonoscopy preparation the day prior to their scheduled colonoscopy. Lubiprostone Group: The lubiprostone group will receive an additional two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the oral 4L PEG preparation). Randomization Scheme: Subjects will be assigned to the Control Group or Lubiprostone Group, on an odd/even basis. After research informed consent has been obtained, subjects are given a study ID numbered 1 through 120. Subjects with an odd number will be assigned to Control Group, and subjects with an even number will be assigned to the Lubiprostone Group. Subjects then will be given a randomization package consisting of the preparation orders, supplies, instructions and the date of their procedure by the investigator obtaining informed consent. The colonoscopist will be blinded to which preparation was given. Only diabetic patients who require an outpatient colonoscopy by a gastroenterologist at the outpatient MCG Clinic will be eligible for the study. Patients will be presented with a separate consent form for the colonoscopy procedure itself. Standard of Care Procedures
Study Procedures
After the procedure, the physician who performed the colonoscopy will complete a form that rates the quality of the subject's colonoscopy preparation on a 1-5 rating scale. The subject's study participation duration is two days (day of preparation and day of procedure). No follow-up visits will occur. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: Lubiprostone
Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep).
Other Names:
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 60 | ||||
Completion Date | March 2010 | ||||
Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00689026 | ||||
Other Study ID Numbers ICMJE | MCG 08-02-186 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sherman M. Chamberlain, M.D., FACP, AGAF, FACG, Assistant Professor of Medicine, Medical College of Georgia | ||||
Study Sponsor ICMJE | Georgia Health Sciences University | ||||
Collaborators ICMJE | Takeda Pharmaceuticals North America, Inc. | ||||
Investigators ICMJE |
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Information Provided By | Georgia Health Sciences University | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |