Pain
Conditions
Keywords
posttraumatic pain
Brief summary
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Interventions
DRUGCelecoxib
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
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Impressions at Final Visit (the Number of Participants Who Have Rated Excellent and Good) | 8 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | 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) | 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 | 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) | 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 | 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) | 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 | 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) | 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 | 6 hours | 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 |
| Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | 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) | 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. |
| Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 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 | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 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 | Baseline, Days 4 (Visit 2) and 8 (Visit 3) | 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 | 8 days | The number of subjects who withdrew due to insufficient clinical response was evaluated. |
| Summary of Adverse Events | 8 days | 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. |
| Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | Two, 4 and 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were screened at 12 centers in Japan.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Celecoxib |
|---|---|
| Age, Continuous | 37.1 Years STANDARD_DEVIATION 14.4 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
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.
Time frame: 8 days
Population: The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Patient Impressions at Final Visit (the Number of Participants Who Have Rated Excellent and Good) | 70 Participants |
Secondary
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.
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)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 1, 4 hours post first dose (n=80) | 17.4 mm | Standard Deviation 16 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 1, 6 hours post first dose (n=80) | 19.6 mm | Standard Deviation 16.3 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 1, before sleep (n=80) | 21.8 mm | Standard Deviation 16.8 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 5, before sleep (n=68) | 45.4 mm | Standard Deviation 19.5 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 6, on awakening (n=68) | 48.0 mm | Standard Deviation 17.7 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Visit 3 (Day 8) (n=73) | 52.4 mm | Standard Deviation 15.5 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Final Visit (LOCF, n=80) | 52.6 mm | Standard Deviation 15.2 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 1, 2 hours post first dose (n=80) | 12.6 mm | Standard Deviation 14.8 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 2, on awakening (n=80) | 25.1 mm | Standard Deviation 19.1 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 2, before sleep (n=80) | 30.9 mm | Standard Deviation 20.8 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 3, on awakening (n=80) | 35.1 mm | Standard Deviation 18.7 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 3, before sleep (n=78) | 37.9 mm | Standard Deviation 18.8 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 4, on awakening (n=78) | 41.3 mm | Standard Deviation 19.7 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 4, before sleep (n=73) | 41.8 mm | Standard Deviation 19.2 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 5, on awakening (n=73) | 44.3 mm | Standard Deviation 18.4 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 6, before sleep (n=68) | 48.8 mm | Standard Deviation 18.1 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 7, on awakening (n=68) | 49.2 mm | Standard Deviation 19 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 7, before sleep (n=55) | 50.2 mm | Standard Deviation 18.7 |
| Celecoxib | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose | Day 8, on awakening (n=55) | 51.3 mm | Standard Deviation 17.3 |
Secondary
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.
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)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Baseline (n=80) | 59.9 mm | Standard Deviation 11.4 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 1, 2 hours post first dose (n=80) | 47.3 mm | Standard Deviation 19.5 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 1, 4 hours post first dose (n=80) | 42.5 mm | Standard Deviation 20.5 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 1, 6 hours post first dose (n=80) | 40.3 mm | Standard Deviation 20.9 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 1, before sleep (n=80) | 38.1 mm | Standard Deviation 20 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 2, on awakening (n=80) | 34.8 mm | Standard Deviation 21.5 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 3, on awakening (n=80) | 24.8 mm | Standard Deviation 20 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 3, before sleep (n=78) | 21.8 mm | Standard Deviation 19.1 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 4, on awakening (n=78) | 18.4 mm | Standard Deviation 19.6 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 4, before sleep (n=73) | 17.8 mm | Standard Deviation 18.9 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 5, on awakening (n=73) | 15.3 mm | Standard Deviation 18 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 5, before sleep (n=68) | 15.0 mm | Standard Deviation 18.7 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 6, on awakening (n=68) | 12.4 mm | Standard Deviation 17.2 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Final Visit (LOCF, n=80) | 7.3 mm | Standard Deviation 13.4 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 2, before sleep (n=80) | 29.0 mm | Standard Deviation 22 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 6, before sleep (n=68) | 11.6 mm | Standard Deviation 17.3 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 7, on awakening (n=68) | 11.3 mm | Standard Deviation 18.1 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 7, before sleep (n=55) | 9.7 mm | Standard Deviation 16.2 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Day 8, on awakening (n=55) | 8.6 mm | Standard Deviation 13.3 |
| Celecoxib | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose | Visit 3 (Day 8) (n=73) | 7.2 mm | Standard Deviation 13 |
Secondary
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.
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)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | Day 1, 6 hours post first dose (n=80) | 44 Participants |
| Celecoxib | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | Day 1, before sleep (n=80) | 48 Participants |
| Celecoxib | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | Day 2, before sleep (n=80) | 55 Participants |
| Celecoxib | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | Visit 2 (Day 4), (n=80) | 60 Participants |
| Celecoxib | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good) | Visit 3 (Day 8), (n=68) | 60 Participants |
Secondary
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.
Time frame: Two, 4 and 6 hours post first dose
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Celecoxib | Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | Pain at rest (n=80) | 22.2 mm |
| Celecoxib | Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | Pain on active movement (n=77) | 26.7 mm |
Secondary
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.
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)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 1, 2 hours post first dose (n=77) | 14.3 mm | Standard Deviation 16.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 1, 4 hours post first dose (n=77) | 20.4 mm | Standard Deviation 17.1 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 1, 6 hours post first dose (n=77) | 24.3 mm | Standard Deviation 17.5 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 1, before sleep (n=77) | 26.5 mm | Standard Deviation 17.5 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 7, on awakening (n=66) | 59.6 mm | Standard Deviation 21.4 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 7, before sleep (n=55) | 62.1 mm | Standard Deviation 20.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 8, on awakening (n=55) | 63.3 mm | Standard Deviation 20.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Visit 3 (Day 8) (n=71) | 63.6 mm | Standard Deviation 18.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Final Visit (LOCF, n=78) | 63.7 mm | Standard Deviation 18.1 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 2, on awakening (n=77) | 30.3 mm | Standard Deviation 19.2 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 2, before sleep (n=77) | 36.1 mm | Standard Deviation 22 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 3, on awakening (n=77) | 40.2 mm | Standard Deviation 21.2 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 3, before sleep (n=75) | 43.2 mm | Standard Deviation 21.5 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 4, on awakening (n=75) | 48.5 mm | Standard Deviation 22.3 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 4, before sleep (n=70) | 49.5 mm | Standard Deviation 20.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 5, on awakening (n=70) | 52.5 mm | Standard Deviation 20.8 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 5, before sleep (n=66) | 53.5 mm | Standard Deviation 21.6 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 6, on awakening (n=66) | 57.5 mm | Standard Deviation 19.7 |
| Celecoxib | PID in Pain on Active Movement Within 8 Days Post-first Dose | Day 6, before sleep (n=66) | 58.4 mm | Standard Deviation 19.9 |
Secondary
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.
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)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Baseline (n=79) | 75.5 mm | Standard Deviation 12.7 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 1, 2 hours post first dose (n=77) | 61.4 mm | Standard Deviation 20.2 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 1, 4 hours post first dose (n=77) | 55.3 mm | Standard Deviation 21 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 1, 6 hours post first dose (n=77) | 51.5 mm | Standard Deviation 20.6 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 1, before sleep (n=77) | 49.3 mm | Standard Deviation 21 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 2, on awakening (n=77) | 45.5 mm | Standard Deviation 21.4 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 2, before sleep (n=77) | 39.7 mm | Standard Deviation 22.6 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 3, on awakening (n=77) | 35.5 mm | Standard Deviation 22.3 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 3, before sleep (n=75) | 32.4 mm | Standard Deviation 21.8 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 4, on awakening (n=75) | 27.2 mm | Standard Deviation 22.9 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 4, before sleep (n=70) | 26.4 mm | Standard Deviation 21 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 5, on awakening (n=70) | 23.5 mm | Standard Deviation 21.4 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 5, before sleep (n=66) | 23.2 mm | Standard Deviation 22 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 6, on awakening (n=66) | 19.2 mm | Standard Deviation 20.4 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 6, before sleep (n=66) | 18.2 mm | Standard Deviation 20.1 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 7, on awakening (n=66) | 17.1 mm | Standard Deviation 21.7 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 7, before sleep (n=55) | 15.5 mm | Standard Deviation 20.7 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Day 8, on awakening (n=55) | 14.3 mm | Standard Deviation 20 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Visit 3 (Day8) (n=71) | 12.1 mm | Standard Deviation 18.7 |
| Celecoxib | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose | Final Visit (LOCF, n=78) | 11.8 mm | Standard Deviation 18.7 |
Secondary
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.
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | None at Baseine (n=80) | 8 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | None at Visit 2 (Day 4) (n=80) | 63 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | None at Visit 3 (Day 8) (n=68) | 66 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | None at Final Visit (n=80) | 76 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Mild at Baseine (n=80) | 43 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Mild at Visit 2 (Day 4) (n=80) | 17 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Mild at Visit 3 (Day 8) (n=68) | 2 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Mild at Final Visit (n=80) | 4 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Moderate at Baseine (n=80) | 23 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Moderate at Visit 2 (Day 4) (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Moderate at Visit 3 (Day 8) (n=68) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Moderate at Final Visit (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Severe at Baseine (n=80) | 6 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Severe at Visit 2 (Day 4) (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Severe at Visit 3 (Day 8) (n=68) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose | Severe at Final Visit (n=80) | 0 Participants |
Secondary
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.
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | None at Baseline (n=80) | 16 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | None at Visit 2 (Day 4) (n=80) | 51 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Mild at Baseline (n=80) | 40 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Mild at Visit 2 (Day 4) (n=80) | 28 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Mild at Visit 3 (Day 8) (n=68) | 4 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Mild at Final Visit (n=80) | 7 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Moderate at Baseline (n=80) | 19 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Moderate at Visit 2 (Day 4) (n=80) | 1 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Moderate at Visit 3 (Day 8) (n=68) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Moderate at Final Visit (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Severe at Baseline (n=80) | 5 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Severe at Visit 2 (Day 4) (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Severe at Visit 3 (Day 8) (n=68) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | Severe at Final Visit (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | None at Visit 3 (Day 8) (n=68) | 64 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose | None at Final Visit (n=80) | 73 Participants |
Secondary
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.
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Moderate at Baseline (n=80) | 48 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Moderate at Visit 2 (Day 4) (n=80) | 5 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Moderate at Visit 3 (Day 8) (n=68) | 4 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Moderate at Final Visit (n=80) | 4 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Severe at Baseline (n=80) | 8 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Severe at Visit 2 (Day 4) (n=80) | 1 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Severe at Visit 3 (Day 8) (n=68) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Severe at Final Visit (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | None at Baseline (n=80) | 0 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | None at Visit 2 (Day 4) (n=80) | 5 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | None at Visit 3 (Day 8) (n=68) | 38 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | None at Final Visit (n=80) | 41 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Mild at Baseline (n=80) | 24 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Mild at Visit 2 (Day 4) (n=80) | 69 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Mild at Visit 3 (Day 8) (n=68) | 26 Participants |
| Celecoxib | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose | Mild at Final Visit (n=80) | 35 Participants |
Secondary
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.
Time frame: 8 days
Population: The safety analysis set consisted of all patients who had taken at least one study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Summary of Adverse Events | AEs: all-causality | 10 Participants |
| Celecoxib | Summary of Adverse Events | AEs: treatment-related | 8 Participants |
| Celecoxib | Summary of Adverse Events | Severe AEs: all-causality | 0 Participants |
| Celecoxib | Summary of Adverse Events | Severe AEs: treatment-realted | 0 Participants |
| Celecoxib | Summary of Adverse Events | Serious AEs: all-causality | 0 Participants |
| Celecoxib | Summary of Adverse Events | Serious AEs: treatment-related | 0 Participants |
| Celecoxib | Summary of Adverse Events | Discontinuation due to all-causality AEs | 1 Participants |
| Celecoxib | Summary of Adverse Events | Discontinuation due to treatment-related AEs | 1 Participants |
| Celecoxib | Summary of Adverse Events | DR/TD due to all-causality AEs | 0 Participants |
| Celecoxib | Summary of Adverse Events | DR/TD due to treatment-related AEs | 0 Participants |
Secondary
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
Time frame: 6 hours
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Celecoxib | Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | Pain at rest (n=80) | 99.3 mm |
| Celecoxib | Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose | Pain on active movement (n=77) | 118.2 mm |
Secondary
Withdrawal Due to Lack of Efficacy
The number of subjects who withdrew due to insufficient clinical response was evaluated.
Time frame: 8 days
Population: The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Withdrawal Due to Lack of Efficacy | 0 Participants |