IngentaConnect Safety and Colon-Cleansing Efficacy of a New Residue-Free Formula...

Authors: Rex, Douglas K.¹; Schwartz, Howard²; Goldstein, Michael³; Popp, John⁴; Katz, Seymour⁵; Barish, Charles⁶; Karlstadt, Robyn G.⁷; Rose, Martin⁷; Walker, Kelli⁷; Lottes, Sandra⁷; Ettinger, Nancy⁷; Zhang, Bing⁸

Source: The American Journal of Gastroenterology, Volume 101, Number 11, November 2006 , pp. 2594-2604(11)

Publisher: Blackwell Publishing

Abstract:

OBJECTIVE: A residue-free sodium phosphate tablet (RF-NaP) was formulated that lacks microcrystalline cellulose, which can appear as a whitish residue in the colon. A multicenter, randomized, investigator-blinded study was conducted to compare the colon-cleansing efficacy of 40 or 32 tablets of RF-NaP with the marketed 40-tablet NaP treatment regimen.

METHODS: Eight hundred sixteen patients were randomized prior to colonoscopy to receive either 40 tablets (60 g) of NaP or RF-NaP or 32 tablets (48 g) of RF-NaP. Colon cleansing was assessed using a 4-point scale based on retained “colonic contents.” The primary end point was overall colon-cleansing response rate to treatment (score of excellent/good) versus nonresponse (fair/inadequate).

RESULTS: Seven hundred four patients were included in the efficacy analysis. The overall colon-cleansing response rates were comparable among treatment arms (94.5%, 97.0%, and 95.3% for NaP, RF-NaP 40, and RF-NaP 32 tablets, respectively). Ascending colon-cleansing response rates for RF-NaP 40 (95.7%) and 32 tablets (93.6%) were significantly better than for NaP tablets (88.5%, p < 0.03 for both). Patients treated with RF-NaP 32 tablets experienced less pronounced changes in electrolyte levels and fewer adverse events (138/239, 58%) compared with patients receiving NaP (161/238, 68%, p= 0.07) and RF-NaP 40 tablets (156/236, 66%, p= 0.03). The most common adverse events reported were abdominal distention, nausea, abdominal pain, and vomiting.

CONCLUSIONS: Based on the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimen was superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing prior to colonoscopy.

(Am J Gastroenterol 2006;101:2594-2604)

Document Type: Research article

DOI: 10.1111/j.1572-0241.2006.00776.x

Affiliations: 1: Indiana University Medical Center, Indianapolis, Indiana 2: Miami Research Associates, Miami, Florida 3: Long Island Gastrointestinal Research, Great Neck, New York 4: Columbia Gastroenterology Associates, Columbia, South Carolina 5: Long Island Clinical Research Associates, Great Neck, New York 6: Wake Research Associates, LLC, Raleigh, North Carolina 7: Salix Pharmaceuticals, Inc., Morrisville, North Carolina 8: MacroStat Inc., Hockessin, Delaware

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Safety and Colon-Cleansing Efficacy of a New Residue-Free Formulation of Sodium Phosphate Tablets