Overview

An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Celecoxib
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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