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
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 |
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
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 |