Parecoxib in Renal Colic

A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic

This is a phase III, multicenter, randomized, single blind study designed to evaluate the efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the treatment of acute pain due to renal colic.

This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to terminate the trial was not based on any safety concerns.

Inclusion Criteria:

• diagnosis of renal colic;
• baseline pain > 50 mm on VAS;

Exclusion Criteria:

• evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
• active GI disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study