Status:
TERMINATED
Efficacy of Lubiprostone in Combination With Standard PEG Preparation
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
50+ years
Phase:
NA
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 req...
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 4 Liters (4L) PEG alone on pre...
Eligibility Criteria
Inclusion
- Patients with known diabetes (type I or II) undergoing elective colonoscopy at the Medical College of Georgia.
- Patients aged 50 years and older.
- Women must be post-menopausal or surgically sterile.
- Patients able to give a valid, informed consent.
Exclusion
- Patients with impaired glucose tolerance.
- Patients with suspected acute or chronic pseudo-obstruction.
- Patients with active gastrointestinal bleeding.
- Patients with known inflammatory bowel disease.
- Patients with chronic diarrhea.
- Patients with prior colonic resection.
- Patients with active diverticulitis.
- Patients with a known colonic mass.
- Patients with clinical evidence of decompensated liver disease.
- Patients with clinical evidence of decompensated renal disease or patients on dialysis.
- Patients currently or previously taking lubiprostone.
- Patients with an allergy to lubiprostone.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00689026
Start Date
May 1 2008
End Date
March 1 2010
Last Update
October 20 2014
Active Locations (1)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912