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

Condition(s) targeted: Low Back Pain

Intervention: Celecoxib (Drug); Placebo (Drug); Loxoprofen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary outcome: Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Tokyo 140-0011, Japan

Pfizer Investigational Site, Chiba 266-0031, Japan

Pfizer Investigational Site, Fukuoka, Japan

Pfizer Investigational Site, Fukuoka 810-0004, Japan

Pfizer Investigational Site, Funabashi-shi, Chiba, Japan

Pfizer Investigational Site, Matsudo-shi, Chiba, Japan

Pfizer Investigational Site, Funabashi, Chiba 273-0035, Japan

Pfizer Investigational Site, Fukuoka-shi, Fukuoka, Japan

Pfizer Investigational Site, Sapporo-shi, Hokkaido, Japan

Pfizer Investigational Site, Sapporo, Hokkaido, Japan

Pfizer Investigational Site, Chitose, Hokkaido 066-0026, Japan

Pfizer Investigational Site, Nishinomiya, Hyogo 662-0838, Japan

Pfizer Investigational Site, Kobe, Hyogo 650 0004, Japan

Pfizer Investigational Site, Katougun, Hyogo 673-1462, Japan

Pfizer Investigational Site, Sagamihara-shi, Kanagawa, Japan

Pfizer Investigational Site, Yokohama-shi, Kanagawa, Japan

Pfizer Investigational Site, Yokohama, Kanagawa, Japan

Pfizer Investigational Site, Tokorozawa, Saitama, Japan

Pfizer Investigational Site, Minamisaitama-gun, Saitama, Japan

Pfizer Investigational Site, Saitama-shi, Saitama, Japan

Pfizer Investigational Site, Hatogaya-shi, Saitama, Japan

Pfizer Investigational Site, Kumagayashi, Saitama 3600854, Japan

Pfizer Investigational Site, Kumagaya-shi, Saitama 3600012, Japan

Pfizer Investigational Site, Adachi-Ku, Tokyo, Japan

Pfizer Investigational Site, Itabashi-ku, Tokyo, Japan

Pfizer Investigational Site, Sumida-ku, Tokyo 131-0043, Japan

Pfizer Investigational Site, Bunkyou-ku, Tokyo, Japan

Pfizer Investigational Site, Edogawa-ku, Tokyo, Japan

Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan

Pfizer Investigational Site, Suginami-ku, Tokyo, Japan

Pfizer Investigational Site, Ota-Ku, Tokyo, Japan

Pfizer Investigational Site, Meguro-Ku, Tokyo, Japan

Pfizer Investigational Site, Shinjyuku-ku, Tokyo, Japan

Pfizer Investigational Site, Meguro-ku, Tokyo, Japan

Pfizer Investigational Site, Shibuya-ku, Tokyo, Japan

Pfizer Investigational Site, Nerima-ku, Tokyo, Japan

Pfizer Investigational Site, ,Shinjyuku-ku, Tokyo, Japan

Pfizer Investigational Site, Nakano-ku, Tokyo, Japan

Pfizer Investigational Site, Toyoshima-ku, Tokyo, Japan

Pfizer Investigational Site, koito-ku, Tokyo, Japan

Pfizer Investigational Site, Shinagawa-ku, Tokyo 140-0001, Japan

Pfizer Investigational Site, Ota-Ku, Tokyo 145-0066, Japan

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Clinical Study Results

Starting date: October 2004
Last updated: September 19, 2007