Trial intelligence / Profile preview

Celecoxib in patients with posttraumatic pain

NCT00976716Phase 3

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Nov 2009
Countries: 1
Sponsor: Viatris
Modality: Orthosteric Ligands

Drugs: celecoxib
Conditions: Chronic Posttraumatic Pain

Overview

Phase 3, open-label, single-arm trial of celecoxib in Chronic Posttraumatic Pain, sponsored by Viatris. Primary endpoint: Patient Impressions at Final Visit at 8 days. Started Sep 2009; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Celecoxib
Celecoxib 400mg initial dose, then 200mg, followed by 200mg BID for 8 days.

Who it enrols

Patients with posttraumatic pain controllable with oral NSAIDs, moderate to severe pain intensity, and inflammation. Excludes patients who received analgesics/anesthetics for the injury or have aspirin-induced asthma or significant cardiovascular history.

Endpoints

Primary

Patient Impressions at Final Visit8 days

Secondary

Patient Impressions Within 8 Days Post-first DoseDay 8
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain)Day 8
Pain Intensity (PI) of Pain on Active MovementDay 8
Pain Intensity Differences (PID) in Pain at RestDay 8
Pain Intensity Differences (PID) in Pain on Active MovementDay 8
Sum of Pain Intensity Differences (SPID)6 hours
Peak Pain Intensity Difference (PPID)6 hours
Severity of Inflammatory Symptoms (Swelling, Redness, Localized Warmth)Day 8

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