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

Viatris

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976716

A3191357

Details and patient eligibility

About

To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Celecoxib

Experimental group

Treatment:

Drug: Celecoxib