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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salvador, BA, 40420-000 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 6 weeks after the
last acute low back pain episode

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00640432
Pfizer
Completed
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

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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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00640432
A3191064
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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