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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

March 17, 2008
April 2, 2008
October 2003
Not Provided
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00640432 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Active Comparator: A
    Intervention: Drug: Diclofenac
  • Experimental: B
    Intervention: Drug: Celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
October 2004
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00640432
A3191064
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP