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

Phase 3

Completed

• Conditions: Low Back Pain

• Registration Number: NCT00141154
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary Outcome Measures

Name	Time	Method
Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Tokyo, Japan