Status:
COMPLETED
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Eligibility Criteria
Inclusion
- Patients with posttraumatic pain which is able to be controlled with an oral NSAID
- Patients with "pain" that meets both of the following criteria within 48 hours after injury:
- "Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
- Patients with "inflammation" that meets the following criteria within 48 hours after injury.
- "Inflammation" Categorical: "Mild", "Moderate" or "Severe"
Exclusion
- Patients who have received analgesics and anaesthetics for injury
- Patients with a history/complication of aspirin-induced asthma
- Patients taking excluded medications
- Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00976716
Start Date
September 1 2009
End Date
November 1 2009
Last Update
February 2 2021
Active Locations (11)
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1
Pfizer Investigational Site
Funabashi, Chiba, Japan
2
Pfizer Investigational Site
Ichikawa, Chiba, Japan
3
Pfizer Investigational Site
Matsudo, Chiba, Japan
4
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan