Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

Viatris

Status and phase

Completed

Phase 3

Conditions

Low Back Pain

Treatments

Drug: Celecoxib

Drug: Placebo

Drug: Loxoprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141154

A3191174

Details and patient eligibility

About

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.

Enrollment

1,234 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
Patients who have had low back pain for at least two weeks

Exclusion criteria

Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain