A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

Viatris

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: tramadol HCL; Drug: celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662558

A3191338

Details and patient eligibility

About

To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6

Enrollment: 802 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used

Exclusion criteria

• The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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802 participants in 2 patient groups

celecoxib

Experimental group

Treatment:

Drug: celecoxib

tramadol

Active Comparator group

Treatment:

Drug: tramadol HCL