Status:

COMPLETED

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

Lead Sponsor:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Conditions:

Low Back Pain

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2004

    Estimated Enrollment :

    244 Patients enrolled

    Trial Details

    Trial ID

    NCT00640432

    Start Date

    October 1 2003

    End Date

    October 1 2004

    Last Update

    February 2 2021

    Active Locations (9)

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    Page 1 of 3 (9 locations)

    1

    Pfizer Investigational Site

    Salvador, Estado de Bahia, Brazil, 40420-000

    2

    Pfizer Investigational Site

    Goiânia, Goiás, Brazil, 74043-110

    3

    Pfizer Investigational Site

    Goiânia, Goiás, Brazil, 74075-020

    4

    Pfizer Investigational Site

    Goiânia, Goiás, Brazil, 74605-050