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”

To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Diclofenac
  • 75 mg oral capsule twice daily for 7 days
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Experimental: B

Primary Measures

• Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
  • Time Frame: Day 3
    Safety Issue?: No

Secondary Measures

• Subject's quality of life, as measured by the SF-36 Health Survey
  • Time Frame: Day 7
    Safety Issue?: No
• Physical examination
  • Time Frame: Days 3 and 7
    Safety Issue?: Yes
• Pain relief score
  • Time Frame: Days 3 and 7
    Safety Issue?: No
• Vital signs
  • Time Frame: Days 3 and 7
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Days 3 and 7
    Safety Issue?: Yes
• Change from baseline in VAS pain intensity assessment
  • Time Frame: Day 7
    Safety Issue?: No
• Categorical pain intensity score
  • Time Frame: Days 3 and 7
    Safety Issue?: No
• Subject's global assessment score
  • Time Frame: Days 3 and 7
    Safety Issue?: No
• Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
  • Time Frame: Day 7
    Safety Issue?: No

Inclusion criteria:

• Aged between 18 and 65 years
• Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
• Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode

Exclusion criteria:

• Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
• Low back pain from major trauma or visceral disorder
• Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640432

Study ID Number: A3191064

ClinicalTrials.gov Identifier: NCT00640432

Health Authority: Brazil: Ministry of Health

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting: