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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141154
First Posted: September 1, 2005
Last Update Posted: May 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Low Back Pain Drug: Celecoxib Drug: Placebo Drug: Loxoprofen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's pain assessment (VAS: Visual Analogue Scale)

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

Enrollment: 1234
Study Start Date: October 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141154


Locations
Japan
Pfizer Investigational Site
Funabashi-shi, Chiba, Japan
Pfizer Investigational Site
Funabashi, Chiba, Japan, 273-0035
Pfizer Investigational Site
Matsudo-shi, Chiba, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan
Pfizer Investigational Site
Chitose, Hokkaido, Japan, 066-0026
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Katougun, Hyogo, Japan, 673-1462
Pfizer Investigational Site
Kobe, Hyogo, Japan, 650 0004
Pfizer Investigational Site
Nishinomiya, Hyogo, Japan, 662-0838
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Hatogaya-shi, Saitama, Japan
Pfizer Investigational Site
Kumagaya-shi, Saitama, Japan, 3600012
Pfizer Investigational Site
Kumagayashi, Saitama, Japan, 3600854
Pfizer Investigational Site
Minamisaitama-gun, Saitama, Japan
Pfizer Investigational Site
Saitama-shi, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
,Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Adachi-Ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyou-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Itabashi-ku, Tokyo, Japan
Pfizer Investigational Site
Koito-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-Ku, Tokyo, Japan
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Nerima-ku, Tokyo, Japan
Pfizer Investigational Site
Ota-Ku, Tokyo, Japan, 145-0066
Pfizer Investigational Site
Ota-Ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan, 140-0001
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Suginami-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan, 131-0043
Pfizer Investigational Site
Toyoshima-ku, Tokyo, Japan
Pfizer Investigational Site
Chiba, Japan, 266-0031
Pfizer Investigational Site
Fukuoka, Japan, 810-0004
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Tokyo, Japan, 140-0011
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00141154     History of Changes
Other Study ID Numbers: A3191174
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: May 30, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Celecoxib
Loxoprofen
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents