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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00640432 |
Purpose
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Diclofenac Drug: Celecoxib |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain |
| Enrollment: | 244 |
| Study Start Date: | October 2003 |
| Study Completion Date: | October 2004 |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: Diclofenac
75 mg oral capsule twice daily for 7 days
|
| B: Experimental |
Drug: Celecoxib
400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Brazil, BA | |
| Pfizer Investigational Site | |
| Salvador, BA, Brazil, 40420-000 | |
| Brazil, GO | |
| Pfizer Investigational Site | |
| Goiânia, GO, Brazil, 74605-050 | |
| Pfizer Investigational Site | |
| Goiânia, GO, Brazil, 74075-020 | |
| Pfizer Investigational Site | |
| Goiânia, GO, Brazil, 74043-110 | |
| Brazil, PR | |
| Pfizer Investigational Site | |
| Londrina, PR, Brazil, 86010-010 | |
| Brazil, RJ | |
| Pfizer Investigational Site | |
| Rio de Janeiro, RJ, Brazil, 21215-020 | |
| Pfizer Investigational Site | |
| Rio de Janeiro, RJ, Brazil, 21941-590 | |
| Brazil, SP | |
| Pfizer Investigational Site | |
| São Paulo, SP, Brazil, 04039-004 | |
| Pfizer Investigational Site | |
| São Paulo, SP, Brazil, 08270-070 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A3191064 |
| Study First Received: | March 17, 2008 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00640432 History of Changes |
| Health Authority: | Brazil: Ministry of Health |
|
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Nervous System Diseases Low Back Pain Diclofenac Enzyme Inhibitors Pain Back Pain |
Pharmacologic Actions Signs and Symptoms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Neurologic Manifestations Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |