Efficacy of Lubiprostone in Combination With Standard PEG Preparation
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.
Timeline
- Start
- 2008-05
- Primary completion
- 2010-03
- Completion
- 2010-03
Outcome
Missed primary endpoint
paper Average colon preparation score Grp L = 2.47 and Grp C = 3.00, P = 0.09. PMID 21160617 ↗
paper Although this was not statistically significant, there was a trend towards improved colon prep in Grp L. PMID 21160617 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lubiprostone | Small molecule | 24 ug | Oral |