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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00640432
First received: March 17, 2008
Last updated: April 2, 2008
Last verified: March 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

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

Enrollment: 244
Study Start Date: October 2003
Study Completion Date: October 2004
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640432

Locations
Brazil
Pfizer Investigational Site
Salvador, BA, Brazil, 40420-000
Pfizer Investigational Site
Goiânia, GO, Brazil, 74605-050
Pfizer Investigational Site
Goiânia, GO, Brazil, 74075-020
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00640432     History of Changes
Other Study ID Numbers: A3191064
Study First Received: March 17, 2008
Last Updated: April 2, 2008
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013