Efficacy of Lubiprostone in Combination With Standard PEG Preparation

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.