Original articleSafety of Celecoxib in Patients With Ulcerative Colitis in Remission: A Randomized, Placebo-Controlled, Pilot Study
Section snippets
Patients
This multicenter, randomized, double-blind, placebo-controlled, pilot trial was conducted at 34 centers in Argentina, Canada, Croatia, Denmark, Russia, Sweden, Turkey, and the United States between August 13, 2001, and March 10, 2004. The protocol was approved by the institutional review board at each center. All patients gave written informed consent.
The criteria for eligibility for the trial included men and women (18–75 years of age) with a history of ulcerative colitis, previously
Characteristics of the Patients
Figure 1 shows the enrollment and treatment of patients in the trial. The baseline characteristics of the patients who were randomized to celecoxib were similar to those of patients randomized to placebo (Table 2).
Ulcerative Colitis Disease Exacerbation
The rates of ulcerative colitis disease exacerbation were similar in the 2 groups (Table 3). Among randomized patients who had at least 1 dose of study drug and both an endoscopy assessment and a Mayo Clinic score at the baseline and final assessments (the prespecified primary
Discussion
Safe analgesic therapy for selected extraintestinal manifestations of ulcerative colitis including colitis-associated arthritis, sacroileitis, and ankylosing spondylitis, and for the treatment of acute pain in patients with ulcerative colitis, constitute important unmet medical needs. The results of our pilot safety trial indicate that short-term treatment with the selective cyclooxygenase-2 inhibitor celecoxib for up to 14 days did not have a greater clinical and endoscopic relapse rate than
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Supported by a research grant from Pfizer Inc, Ann Arbor, MI. William Sandborn and William Stenson have served as consultants for Pfizer Inc. William Sandborn, William Stenson, and Jørn Brynskov have received research support from Pfizer Inc. Gina Steidle, Jeffery Robbins, and Bradley Bloom are employees of Pfizer Inc. Jeffery Kent is a former employee of Pfizer Inc. Robin G. Lorenz received partial compensation from Pfizer for the pathology services reported in the manuscript.