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Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640432
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : April 7, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Diclofenac Drug: Celecoxib Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2003
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: Diclofenac
75 mg oral capsule twice daily for 7 days
Experimental: B 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

Primary Outcome Measures :
  1. Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment [ Time Frame: Day 3 ]

Secondary Outcome Measures :
  1. Subject's quality of life, as measured by the SF-36 Health Survey [ Time Frame: Day 7 ]
  2. Physical examination [ Time Frame: Days 3 and 7 ]
  3. Pain relief score [ Time Frame: Days 3 and 7 ]
  4. Vital signs [ Time Frame: Days 3 and 7 ]
  5. Adverse events [ Time Frame: Days 3 and 7 ]
  6. Change from baseline in VAS pain intensity assessment [ Time Frame: Day 7 ]
  7. Categorical pain intensity score [ Time Frame: Days 3 and 7 ]
  8. Subject's global assessment score [ Time Frame: Days 3 and 7 ]
  9. Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability [ Time Frame: Day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640432

Pfizer Investigational Site
Salvador, BA, Brazil, 40420-000
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Goiânia, GO, Brazil, 74605-050
Pfizer Investigational Site
Londrina, PR, Brazil, 86010-010
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21215-020
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Pfizer Investigational Site
São Paulo, SP, Brazil, 04039-004
Pfizer Investigational Site
São Paulo, SP, Brazil, 08270-070
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00640432     History of Changes
Other Study ID Numbers: A3191064
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents