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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Celecoxib
Placebo
Loxoprofen
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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)

Full Information

First Posted
August 30, 2005
Last Updated
March 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00141154
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1234 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Loxoprofen
Primary Outcome Measure Information:
Title
Patient's pain assessment (VAS: Visual Analogue Scale)
Secondary Outcome Measure Information:
Title
Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Funabashi-shi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
273-0035
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matsudo-shi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0026
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Katougun
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650 0004
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
662-0838
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hatogaya-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumagaya-shi
State/Province
Saitama
ZIP/Postal Code
3600012
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumagayashi
State/Province
Saitama
ZIP/Postal Code
3600854
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minamisaitama-gun
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokorozawa
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Adachi-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyou-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koito-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Meguro-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nerima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ota-Ku
State/Province
Tokyo
ZIP/Postal Code
145-0066
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ota-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0001
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
131-0043
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toyoshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiba
ZIP/Postal Code
266-0031
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
ZIP/Postal Code
810-0004
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
ZIP/Postal Code
140-0011
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191174&StudyName=Comparison+Of+Celecoxib+200+Mg+Bid%2C+Loxoprofen+Sodium+60+Mg+Tid+And+Placebo+In+Low+Back+Pain+In+Japan
Description
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Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

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