Other Acute Postoperative Pain
Conditions
Brief summary
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
Interventions
DRUGIndomethacin
40 mg TID capsules
DRUGCelecoxib
200 mg capsules
DRUGPlacebo
Capsules
Sponsors
Iroko Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient is male or female between 18 and 65 years of age * For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures * Patient must be willing to stay at the study site ≥ 72 hours
Exclusion criteria
* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs * Patient has a current disease or history of a disease that will impact the study or the patient's well-being * Patient has used or intends to use any of the medications that are prohibited by the protocol * Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test * Patient has taken another investigational drug within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 0 - 48 hours | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 0 - 8 hours | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. |
| VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 0 - 24 hours | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. |
| Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 0 - 4 hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. |
| VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 0 - 4 hours | The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment. |
| TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 0 - 24 hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. |
| TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 0 - 48 hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. |
| TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 0 - 8 hours | Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 200 mg Celecoxib : 200 mg capsules | 93 |
| Indomethacin 20 mg TID Indomethacin : 20 mg TID capsules | 91 |
| Indomethacin 40 mg BID Indomethacin : 40 mg BID capsules | 91 |
| Indomethacin 40 mg TID Indomethacin : 40 mg TID capsules | 93 |
| Placebo Placebo : Capsules | 94 |
| Total | 462 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Celecoxib 200 mg | Indomethacin 20 mg TID | Indomethacin 40 mg BID | Indomethacin 40 mg TID | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 12.3 | 41.5 years STANDARD_DEVIATION 13.4 | 41.4 years STANDARD_DEVIATION 12.4 | 41.5 years STANDARD_DEVIATION 11.4 | 40.4 years STANDARD_DEVIATION 13.3 | 41.2 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 93 participants | 91 participants | 91 participants | 93 participants | 94 participants | 462 participants |
| Sex: Female, Male Female | 77 Participants | 79 Participants | 72 Participants | 79 Participants | 77 Participants | 384 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 19 Participants | 14 Participants | 17 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 93 | 69 / 91 | 74 / 91 | 66 / 93 | 71 / 94 |
| serious Total, serious adverse events | 0 / 93 | 0 / 91 | 1 / 91 | 0 / 93 | 0 / 94 |
Outcome results
Primary
The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
Time frame: 0 - 48 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 508.2 mm*hour | Standard Deviation 1125.6 |
| Indomethacin 40 mg BID | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 329.8 mm*hour | Standard Deviation 903.3 |
| Indomethacin 20 mg TID | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 377.3 mm*hour | Standard Deviation 1045.1 |
| Celecoxib 200 mg | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 280.5 mm*hour | Standard Deviation 799.8 |
| Placebo | The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48) | 69.4 mm*hour | Standard Deviation 364.3 |
p-value: <0.00195% CI: [187.1, 696.5]ANCOVA
p-value: 0.04695% CI: [4.1, 516.3]ANCOVA
p-value: 0.01795% CI: [56.6, 568.9]ANCOVA
p-value: 0.10395% CI: [-43.1, 466.2]ANCOVA
Secondary
Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Time frame: 0 - 4 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 2.5 units on a scale*hour | Standard Deviation 3.6 |
| Indomethacin 40 mg BID | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 2.1 units on a scale*hour | Standard Deviation 3.4 |
| Indomethacin 20 mg TID | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 1.7 units on a scale*hour | Standard Deviation 2.9 |
| Celecoxib 200 mg | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 1.8 units on a scale*hour | Standard Deviation 2.8 |
| Placebo | Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4). | 1.2 units on a scale*hour | Standard Deviation 2.1 |
p-value: 0.003t-test, 2 sided
p-value: 0.022t-test, 2 sided
p-value: 0.146t-test, 2 sided
p-value: 0.071t-test, 2 sided
Secondary
TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Time frame: 0 - 24 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 13.4 units on a scale*hour | Standard Deviation 26.4 |
| Indomethacin 40 mg BID | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 8.9 units on a scale*hour | Standard Deviation 20.4 |
| Indomethacin 20 mg TID | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 10.0 units on a scale*hour | Standard Deviation 23 |
| Celecoxib 200 mg | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 7.7 units on a scale*hour | Standard Deviation 18.1 |
| Placebo | TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours | 2.6 units on a scale*hour | Standard Deviation 8.8 |
p-value: <0.001t-test, 2 sided
p-value: 0.008t-test, 2 sided
p-value: 0.005t-test, 2 sided
p-value: 0.017t-test, 2 sided
Secondary
TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Time frame: 0 - 48 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 29.3 units on a scale*hour | Standard Deviation 59.8 |
| Indomethacin 40 mg BID | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 17.8 units on a scale*hour | Standard Deviation 45.6 |
| Indomethacin 20 mg TID | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 19.6 units on a scale*hour | Standard Deviation 49.3 |
| Celecoxib 200 mg | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 16.4 units on a scale*hour | Standard Deviation 43.2 |
| Placebo | TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours | 5.2 units on a scale*hour | Standard Deviation 22.9 |
p-value: <0.001t-test, 2 sided
p-value: 0.02t-test, 2 sided
p-value: 0.012t-test, 2 sided
p-value: 0.029t-test, 2 sided
Secondary
TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4. The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.
Time frame: 0 - 8 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 4.5 units on a scale*hour | Standard Deviation 7.4 |
| Indomethacin 40 mg BID | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 3.4 units on a scale*hour | Standard Deviation 6.3 |
| Indomethacin 20 mg TID | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 3.4 units on a scale*hour | Standard Deviation 6.3 |
| Celecoxib 200 mg | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 3.0 units on a scale*hour | Standard Deviation 5.6 |
| Placebo | TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours | 1.5 units on a scale*hour | Standard Deviation 2.9 |
p-value: <0.001t-test, 2 sided
p-value: 0.008t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: 0.016t-test, 2 sided
Secondary
VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
Time frame: 0 - 24 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 226.9 mm*hour | Standard Deviation 500.9 |
| Indomethacin 40 mg BID | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 158.3 mm*hour | Standard Deviation 405.2 |
| Indomethacin 20 mg TID | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 176.9 mm*hour | Standard Deviation 469.6 |
| Celecoxib 200 mg | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 119.4 mm*hour | Standard Deviation 329.6 |
| Placebo | VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry | 28.3 mm*hour | Standard Deviation 132.1 |
p-value: <0.001t-test, 2 sided
p-value: 0.004t-test, 2 sided
p-value: 0.004t-test, 2 sided
p-value: 0.015t-test, 2 sided
Secondary
VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
Time frame: 0 - 4 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 30.7 mm*hour | Standard Deviation 74.9 |
| Indomethacin 40 mg BID | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 29.8 mm*hour | Standard Deviation 70.8 |
| Indomethacin 20 mg TID | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 17.9 mm*hour | Standard Deviation 57.1 |
| Celecoxib 200 mg | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 20.4 mm*hour | Standard Deviation 54.6 |
| Placebo | VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry. | 8.9 mm*hour | Standard Deviation 38.3 |
p-value: 0.013t-test, 2 sided
p-value: 0.014t-test, 2 sided
p-value: 0.211t-test, 2 sided
p-value: 0.098t-test, 2 sided
Secondary
VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.
Time frame: 0 - 8 hours
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indomethacin 40 mg TID | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 64.1 mm*hour | Standard Deviation 144.6 |
| Indomethacin 40 mg BID | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 55.4 mm*hour | Standard Deviation 132.4 |
| Indomethacin 20 mg TID | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 45.7 mm*hour | Standard Deviation 122.7 |
| Celecoxib 200 mg | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 37.2 mm*hour | Standard Deviation 97.4 |
| Placebo | VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry. | 12.0 mm*hour | Standard Deviation 49.9 |
p-value: 0.001t-test, 2 sided
p-value: 0.004t-test, 2 sided
p-value: 0.017t-test, 2 sided
p-value: 0.028t-test, 2 sided