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NCT00141154 Clinical Trial

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

Low Back Pain Clinical Trial

Official title:
A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141154
Other study ID # A3191174
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004

Study information
Verified date March 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1234
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib

• Placebo

• Loxoprofen

Locations
Country Name City State
Japan Pfizer Investigational Site Adachi-Ku Tokyo
Japan Pfizer Investigational Site Bunkyou-ku Tokyo
Japan Pfizer Investigational Site Chiba
Japan Pfizer Investigational Site Chitose Hokkaido
Japan Pfizer Investigational Site Edogawa-ku Tokyo
Japan Pfizer Investigational Site Fukuoka
Japan Pfizer Investigational Site Fukuoka
Japan Pfizer Investigational Site Fukuoka-shi Fukuoka
Japan Pfizer Investigational Site Funabashi Chiba
Japan Pfizer Investigational Site Funabashi-shi Chiba
Japan Pfizer Investigational Site Hatogaya-shi Saitama
Japan Pfizer Investigational Site Itabashi-ku Tokyo
Japan Pfizer Investigational Site Katougun Hyogo
Japan Pfizer Investigational Site Kobe Hyogo
Japan Pfizer Investigational Site Koito-ku Tokyo
Japan Pfizer Investigational Site Kumagaya-shi Saitama
Japan Pfizer Investigational Site Kumagayashi Saitama
Japan Pfizer Investigational Site Matsudo-shi Chiba
Japan Pfizer Investigational Site Meguro-Ku Tokyo
Japan Pfizer Investigational Site Minamisaitama-gun Saitama
Japan Pfizer Investigational Site Nakano-ku Tokyo
Japan Pfizer Investigational Site Nerima-ku Tokyo
Japan Pfizer Investigational Site Nishinomiya Hyogo
Japan Pfizer Investigational Site Ota-Ku Tokyo
Japan Pfizer Investigational Site Ota-Ku Tokyo
Japan Pfizer Investigational Site Sagamihara-shi Kanagawa
Japan Pfizer Investigational Site Saitama-shi Saitama
Japan Pfizer Investigational Site Sapporo Hokkaido
Japan Pfizer Investigational Site Sapporo-shi Hokkaido
Japan Pfizer Investigational Site Setagaya-ku Tokyo
Japan Pfizer Investigational Site Shibuya-ku Tokyo
Japan Pfizer Investigational Site Shinagawa-ku Tokyo
Japan Pfizer Investigational Site Shinjyuku-ku Tokyo
Japan Pfizer Investigational Site Suginami-ku Tokyo
Japan Pfizer Investigational Site Sumida-ku Tokyo
Japan Pfizer Investigational Site Tokorozawa Saitama
Japan Pfizer Investigational Site Tokyo
Japan Pfizer Investigational Site Toyoshima-ku Tokyo
Japan Pfizer Investigational Site Yokohama Kanagawa
Japan Pfizer Investigational Site Yokohama-shi Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient's pain assessment (VAS: Visual Analogue Scale)
Secondary Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)
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