Safety of Celecoxib in Patients With Ulcerative Colitis in Remission: A Randomized, Placebo-Controlled, Pilot Study  William J. Sandborn, William F. Stenson, Jørn Brynskov, Robin G. Lorenz, Gina M. Steidle, Jeffery L. Robbins, Jeffery D. Kent, Bradley J. Bloom  Clinical Gastroenterology and Hepatology  Volume 4, Issue 2, Pages 203-211 (February 2006) DOI: 10.1016/j.cgh.2005.12.002 Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions

Figure 1 Enrollment and treatment of patients. A total of 112 patients with ulcerative colitis in remission were randomized to receive oral therapy with celecoxib 200 mg twice daily for 14 days, and 110 patients were randomized to receive placebo. The safety population was composed of all 221 randomized patients who received at least 1 dose of study medication (112 patients assigned to celecoxib and 109 patients assigned to placebo). The primary efficacy population is composed of 217 randomized patients who had at least 1 dose of study drug, and both an endoscopy score and a Mayo Clinic score at the baseline and final assessments (110 patients randomized to celecoxib and 107 patients randomized to placebo). Clinical Gastroenterology and Hepatology 2006 4, 203-211DOI: (10.1016/j.cgh.2005.12.002) Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions