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

• Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") [ Time Frame: 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) ] [ Designated as safety issue: No ]

  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.

• Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose [ Time Frame: 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) ] [ Designated as safety issue: No ]
  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.
• PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose [ Time Frame: 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) ] [ Designated as safety issue: No ]
  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.
• Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose [ Time Frame: 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) ] [ Designated as safety issue: No ]
  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.
• PID in Pain on Active Movement Within 8 Days Post-first Dose [ Time Frame: 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) ] [ Designated as safety issue: No ]
  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.
• Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  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
• Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [ Time Frame: Two, 4 and 6 hours post first dose ] [ Designated as safety issue: No ]
  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.
• Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ] [ Designated as safety issue: No ]
  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.
• Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ] [ Designated as safety issue: No ]
  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.
• Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ] [ Designated as safety issue: No ]
  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.
• Withdrawal Due to Lack of Efficacy [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  The number of subjects who withdrew due to insufficient clinical response was evaluated.
• Summary of Adverse Events [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  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.

• Pain intensity (VAS:Visual Analog Scale) of pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ] [ Designated as safety issue: No ]
• Pain intensity differences in pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ] [ Designated as safety issue: No ]
• Sum of pain intensity differences in pain at rest (spontaneous pain) and active movement pain until 6 hours after the first dose of study drug [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Peak pain intensity difference in pain at rest (spontaneous pain) and active movement pain until 6 hours after the first dose of study drug [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
• Severity of inflammatory symptoms (each of swelling, redness, and local burn) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
• Patient Impressions (the proportion of subjects who have rated "worked well" and "worked") [ Time Frame: 4 days ] [ Designated as safety issue: No ]
• The assessment of safety [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

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

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