Efficacy and tolerability of a new formulation of sodium phosphate tablets (INKP-101), and a reduced sodium phosphate dose, in colon cleansing: a single-center open-label pilot trial

Alimentary Pharmacology & Therapeutics
M Khashab, Douglas K Rex

Abstract

The tablet form of sodium phosphate for bowel preparation for colonoscopy contains microcrystalline cellulose. This inactive ingredient produces a residue that obscures mucosal visualization and is time-consuming to remove during colonoscopy. To perform an open-label study of efficacy and tolerability of a modified formulation with microcrystalline cellulose reduced by 50% (code named INKP-101) and a lower total dose of sodium phosphate. Patients scheduled for colonoscopy self-administered 28 INKP-101 tablets (42 g sodium phosphate). Colon cleansing efficacy was evaluated using a standard 4-point scoring system and the amount of microcrystalline cellulose present and time spent removing it using an 8-point scale. A total of 31 patients were screened and enrolled. Thirty patients had a colonoscopy and were evaluated for colon cleansing efficacy. Overall colon cleansing was rated as excellent and good in 90% and 10% of patients respectively. About 77% of patients had microcrystalline cellulose scores of 2 or 3 (corresponding to <1 or 1-2 min spent removing microcrystalline cellulose, respectively). The drug was well-tolerated and adverse events were generally benign. A new formulation of sodium phosphate with reduced microcrystal...Continue Reading

Citations

Sep 27, 2012·International Journal of Colorectal Disease·Hiroyuki AiharaHisao Tajiri
Oct 8, 2011·Gastroenterology Nursing : the Official Journal of the Society of Gastroenterology Nurses and Associates·Yavuz BeyazitAysegul Babali
Nov 1, 2008·Digestive Diseases and Sciences·Suryakanth R GuruduJonathan A Leighton
Sep 18, 2007·The American Journal of the Medical Sciences·Daniel E Carl, Domenic A Sica
Aug 13, 2013·Gastroenterology Clinics of North America·Ala I Sharara, Rachel R Abou Mrad
Aug 30, 2007·Gastrointestinal Endoscopy·Carol A Burke, James M Church
Mar 1, 2011·Gastrointestinal Endoscopy·Aliya G Hasan, William R Brown
Jul 27, 2007·The Annals of Pharmacotherapy·Douglas K Rex
May 30, 2014·The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi·Jeong Bae ParkChang Heon Yang
Oct 13, 2006·The American Journal of Gastroenterology·Douglas K RexBing Zhang
Aug 31, 2007·The American Journal of Gastroenterology·Domenic A SicaAlvin M Zfass
Mar 6, 2008·Drugs·Sherief Shawki, Steven D Wexner

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