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NCT01876121 Clinical Trial

Celecoxib Japan Observational Study for the Patients With Acute Pain

Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain Clinical Trial

Official title:
Celecoxib Japan Observational Study for the Patients With Acute Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01876121
Other study ID # COX-05
Secondary ID
Status Completed
Phase N/A
First received June 10, 2013
Last updated September 4, 2014
Start date July 2012
Est. completion date April 2013

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 784
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Acute Pain
  • Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain

Intervention

Drug:
• Celecoxib
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety assessed by the incidence of adverse events and lab-tests For 2 weeks No
Secondary Overall pain improvement assessed by visual analogue scale (VAS) Baseline and week-2 No

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