Parecoxib in Renal Colic

Phase 3TerminatedNCT00139646

Pfizer50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colic

Interventions

ParecoxibDRUG

DiclofenacDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Pfizer Investigational Site

Alessandria, Italy

Pfizer Investigational Site

Grosseto, Italy

Pfizer Investigational Site

Modena, Italy

Pfizer Investigational Site

Pavia, Italy

Pfizer Investigational Site

Outcomes

Primary Outcomes

Evaluation of efficacy through: time to onset of pain relief and time to remedication.

Secondary Outcomes

Evaluation of efficacy through: Pain Intensity (VAS), Pain Relief (PR) and several measurements of analgesia that will be derived from VAS and PR Physician's Global Evaluation at 12 hours Patient's Global Evaluation at 12 hours

Data from ClinicalTrials.gov

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