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

NCT ID: NCT00141154

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Celecoxib

Intervention Type DRUG

Placebo

Intervention Type DRUG

Loxoprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Funabashi, Chiba, Japan

Site Status

Pfizer Investigational Site

Funabashi-shi, Chiba, Japan

Site Status

Pfizer Investigational Site

Matsudo-shi, Chiba, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Chitose, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Katougun, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Nishinomiya, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Sagamihara-shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Hatogaya-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Kumagaya-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Kumagayashi, Saitama, Japan

Site Status

Pfizer Investigational Site

Minamisaitama-gun, Saitama, Japan

Site Status

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Tokorozawa, Saitama, Japan

Site Status

Pfizer Investigational Site

Adachi-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Bunkyou-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Itabashi-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Koito-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Meguro-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakano-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nerima-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Ōta-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Ōta-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Suginami-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Sumida-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Toyoshima-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chiba, , Japan

Site Status

Pfizer Investigational Site

Fukuoka, , Japan

Site Status

Pfizer Investigational Site

Fukuoka, , Japan

Site Status

Pfizer Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A3191174

Identifier Type: -

Identifier Source: org_study_id

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