Parecoxib in Renal Colic

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Colic

Treatments

Drug: Diclofenac

Drug: Parecoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00139646

124-IFL-0505-005

A3481007

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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