Parecoxib in Renal Colic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Parecoxib

Intervention Type DRUG

Diclofenac

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No