Parecoxib in Renal Colic - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139646

Purpose

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.

Condition	Intervention	Phase
Colic	Drug: Parecoxib Drug: Diclofenac	Phase III

Drug Information available for: Parecoxib Parecoxib sodium Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139646

Locations

Italy
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Alessandria, Italy, 15100
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Grosseto, Italy, 58100
Pfizer Investigational Site
Pavia, Italy, 27100

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

Study ID Numbers:	124-IFL-0505-005, A3481007
Study First Received:	August 29, 2005
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00139646
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Parecoxib
Signs and Symptoms, Digestive
Abdominal Pain

Colic
Diclofenac
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009