Celecoxib Japan Observational Study for the Patients With Acute Pain

Completed

• Conditions: Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain
• Interventions: Drug: Celecoxib

• Registration Number: NCT01876121
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 784

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Celecox group	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events and lab-tests	For 2 weeks

Secondary Outcome Measures

Name	Time	Method
Overall pain improvement assessed by visual analogue scale (VAS)	Baseline and week-2