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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celecoxib

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Day 1

* The first dose: Celecoxib 400mg
* The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed

Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)

\- Celecoxib 200mg twice daily

Interventions

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Celecoxib

Day 1

* The first dose: Celecoxib 400mg
* The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed

Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)

\- Celecoxib 200mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No