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P252. Efficacy and safety of a split-dose dual-action, low-volume bowel preparation for colonoscopy: the SEE CLEAR I study

D. Rex1, P. Katz2, G. Bertiger3, J. Masure4, R. Joseph5, 1Indiana University School of Medicine, Indianapolis, United States, 2Albert Einstein Healthcare Network, Philadelphia, United States, 3Hillmont GI, Flourtown, United States, 4Ferring International Center SA, Saint-Prez, Switzerland, 5Ferring Pharmaceuticals Inc, Parsippany, United States

Background

Inadequate bowel cleansing has been shown to decrease detection of precancerous lesions. Split-dose administration of a bowel preparation has been demonstrated to maximise the efficacy of a colonoscopy. Although sodium picosulfate and magnesium citrate have been used in bowel cleansing for more than 3 decades, randomised, controlled studies utilising split dosing have been limited.

Methods

This phase 3, randomised, multicentre, assessor-blinded study, conducted in the United States, investigated the efficacy and safety of split-dose sodium picosulfate and magnesium citrate (P/MC) vs conventional dosing of 2 L polyethylene glycol solution and two 5-mg bisacodyl tablets (PEG + 2 bisacodyl tablets) in adult patients preparing for colonoscopy (NCT01073930, sponsored by Ferring Pharmaceuticals). A modified Aronchick scale was used to assess overall colon cleansing, and the Ottawa scale was used to evaluate cleansing of the colon segments. To assess noninferiority, a 97.5% 1-sided confidence interval (CI) was constructed for the success rate of P/MC minus PEG + 2 bisacodyl tablets. The noninferiority margin was >−9.0%. If noninferiority criteria were satisfied, a test for superiority was performed. If the lower bound of the CI was >0%, superiority was demonstrated.

Results

A total of 603 randomised patients self-administered either P/MC (n = 305) or PEG + 2 bisacodyl tablets (n = 298). P/MC was superior compared with PEG + 2 bisacodyl tablets in overall colon cleansing (CI: 3.4) and in cleansing of the ascending (CI: 4.9), mid (CI: 1.6), and recto-sigmoid (CI: 0.4) segments of the colon. Overall colon cleansing was successful in a greater number of patients receiving P/MC than PEG + 2 bisacodyl tablets (84.2% vs 74.4%). Similarly, the proportion of patients who were successfully cleansed was higher for P/MC than for PEG + 2 bisacodyl tablets in the ascending (89.5% vs 78.8%), mid (92.4% vs 85.9%), and recto-sigmoid (92.4% vs 87.2%) segments of the colon. The incidence of treatment-emergent adverse events (TEAEs) was similar between P/MC and PEG + 2 bisacodyl tablets (69.2% vs 72.8%). Commonly reported TEAEs attributed to P/MC or PEG + 2 bisacodyl tablets were nausea (2.6% vs 3.7%), vomiting (1.0% vs 3.4%), headache (1.6% vs 1.7%), and chills (0% vs 1.0%).

Conclusion

P/MC administered as a split dose in preparation for colonoscopy is superior in colon cleansing and has a similar short-term safety profile compared with day-before dosing of PEG + 2 bisacodyl tablets.