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

Study Overview
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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.

Official Title
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An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Celecoxib


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br> | Drug: Celecoxib<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Impressions at Final Visit (the Number of Participants Who Have Rated Excellent and Good) | The patient impression of the study medication was entered in the patient diary based on the following categories: excellent, good, fair and poor. Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until Final Visit. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | The patient impression of the study medication was entered in the patient diary based on the following categories: excellent, good, fair and poor. Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until each time point. | 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3) | 
| Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) | 
| PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) | 
| Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) | 
| PID in Pain on Active Movement Within 8 Days Post-first Dose | The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. | 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) | 
| Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose | 6 hours | 
| Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient. | Two, 4 and 6 hours post first dose | 
| Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | The investigator assessed the swelling, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 
| Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | The investigator assessed the redness, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 
| Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | The investigator assessed the localized warmth, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 
| Withdrawal Due to Lack of Efficacy | The number of subjects who withdrew due to insufficient clinical response was evaluated. | 8 days | 
| Summary of Adverse Events | The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. | 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic pain