Abstract
Purpose: Visicol is effective and well tolerated as a colonoscopy purgative. The MCC tablet binder may leave a visible residue during procedures. An MCC-free formulation INKP-102, has been developed. The purpose of this randomized, investigator-blinded, multicenter trial was to determine the appropriate dosing regimen for INKP-102. Methods: Eligible, adult colonoscopy pts received one of 6 dosing regimens of INKP-102 or Visicol (see table). Colon-cleansing efficacy was based on response to treatment. A pt was considered to be a responder if Overall Colon Cleansing (OCC) was rated “excellent” or “good” on a 4-point scale based on the amount of retained “colonic contents.” Safety measures were monitored.Table: Phase 2 Dose Ranging Study - OCC Response RateResults: Most adverse events (nausea, abdominal pain, distention, vomiting) were mild or moderate in intensity and occurred with the same frequency or less in the INKP-102 arms compared with Visicol. Conclusions: INKP-102 is a safe and efficacious purgative. “Next day” dosing is preferred but “evening only” dosing with a 32-tablet dose of INKP-102 is also effective.
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