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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib; Diclofenac

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