Parecoxib in Renal Colic

Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00139646
• Other study ID #: 124-IFL-0505-005
• Secondary ID: A3481007
• Status: Terminated
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: May 2, 2008
• Start date: April 2002
• Est. completion date: April 2004

Study information

• Verified date: May 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Parecoxib

• Diclofenac

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Alessandria
Italy	Pfizer Investigational Site	Grosseto
Italy	Pfizer Investigational Site	Modena
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Secondary	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

External Links

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