Clinical trial NCT00141154: Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 1234
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Patient's pain assessment (VAS: Visual Analogue Scale)
Secondary outcomes:
measure: Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)
Other outcomes:
Locations:
city: Funabashi-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Funabashi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matsudo-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Chitose
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Katougun
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Hatogaya-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kumagaya-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kumagayashi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Minamisaitama-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Adachi-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Bunkyou-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Koito-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Ota-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Ota-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toyoshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: