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

March 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 266-0031
        • Pfizer Investigational Site
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Fukuoka, Japan, 810-0004
        • Pfizer Investigational Site
      • Tokyo, Japan, 140-0011
        • Pfizer Investigational Site
    • Chiba
      • Funabashi, Chiba, Japan, 273-0035
        • Pfizer Investigational Site
      • Funabashi-shi, Chiba, Japan
        • Pfizer Investigational Site
      • Matsudo-shi, Chiba, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Chitose, Hokkaido, Japan, 066-0026
        • Pfizer Investigational Site
      • Sapporo, Hokkaido, Japan
        • Pfizer Investigational Site
      • Sapporo-shi, Hokkaido, Japan
        • Pfizer Investigational Site
    • Hyogo
      • Katougun, Hyogo, Japan, 673-1462
        • Pfizer Investigational Site
      • Kobe, Hyogo, Japan, 650 0004
        • Pfizer Investigational Site
      • Nishinomiya, Hyogo, Japan, 662-0838
        • Pfizer Investigational Site
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
        • Pfizer Investigational Site
      • Yokohama, Kanagawa, Japan
        • Pfizer Investigational Site
      • Yokohama-shi, Kanagawa, Japan
        • Pfizer Investigational Site
    • Saitama
      • 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
    • Tokyo
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary Outcome Measures

Outcome Measure
Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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