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

Viatris

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Celecoxib; Drug: Diclofenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640432

A3191064

Details and patient eligibility

About

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

Enrollment: 244 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Diclofenac

B

Experimental group

Treatment:

Drug: Celecoxib