Celecoxib Japan Observational Study for the Patients With Acute Pain

September 4, 2014 updated by: Astellas Pharma Inc
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.

Study Type

Observational

Enrollment (Actual)

784

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
      • Chubu, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with traumatic pain, post-surgical pain and tooth extract pain

Description

Inclusion Criteria:

  • Patients with traumatic pain, post-surgical pain and tooth extract pain

Exclusion Criteria:

  • Hyperreactive to sulfonamide
  • Aspirin asthma patients
  • Peptidic ulcer patients
  • Serious liver disease patients
  • Serious kidney disease patients
  • Serious heart failure patients
  • End of pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Celecox group
Drug: Celecoxib
oral
Other Names:
  • Celecox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by the incidence of adverse events and lab-tests
Time Frame: For 2 weeks
For 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall pain improvement assessed by visual analogue scale (VAS)
Time Frame: Baseline and week-2
Baseline and week-2

Collaborators and Investigators

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

Sponsor

Astellas Pharma 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

July 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COX-05

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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