Arthritis, Gouty
Conditions
Brief summary
This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.
Interventions
DRUGIndomethacin
indomethacin 50 mg three times a day (TID) for 8 days.
DRUGCelecoxib
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout; * Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1); * A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.
Exclusion criteria
* Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint; * Acute polyarticular gout involving greater than 4 joints or chronic gout.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline and Day 2 | The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline, Day 5, Day 9, and Day 14/Early Termination | Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3). |
| Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline, Days 5, 9 and 14/Early Termination | Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3) |
| Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline, Day 5, Day 9 and Day 14/Early Termination | Redness was assessed by the physician as present or absent. |
| Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline, Day 5, Day 9 and Day 14 | Warmth was assessed by the physician as present or absent. |
| Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose) | The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4). |
| Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline, 8, 12, and 24 hours post first dose | Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity |
| Change From Baseline in Patient's Assessment of Pain Intensity | Baseline, Day 2 to Day 13 | The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
| Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | Baseline | The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
| Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Baseline to Day 13 | The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient. |
| Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 to Day 8 | Withdrawal due to lack of efficacy was assessed from Days 1 to 8 |
| Participants Global Evaluation of Study Medication Score | Day 9 | The participant rated the study medication that they received during the study by completing the following question: How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor |
| Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | Baseline to Day 14/Early Termination | The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia) |
| Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | Baseline to Day 14/Early Termination | The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence. |
| Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline, Day 2 | The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
Countries
Canada, Colombia, Costa Rica, Mexico, Peru, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, United States
Participant flow
Pre-assignment details
A total of 443 participants were screened, of which 402 participants were assigned to treatment and 400 received treatment. One participant (indomethacin 50 mg) was not treated as they were no longer willing to participate in the study, and one participant (celecoxib 800/400 mg) was not treated due to due to insufficient drug quantity at site.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 50 mg Participants received Celecoxib 50 mg twice daily for 8 days | 101 |
| Celecoxib 400/200 mg An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days. | 99 |
| Celecoxib 800/400 mg An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days. | 98 |
| Indomethacin 50 mg Indomethacin 50 mg three times daily for 8 days. | 102 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 | 1 | 9 |
| Overall Study | Lack of Efficacy | 9 | 6 | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 2 |
| Overall Study | Other | 9 | 9 | 9 | 11 |
| Overall Study | Randomized but not treated | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Indomethacin 50 mg | Total | Celecoxib 50 mg | Celecoxib 400/200 mg | Celecoxib 800/400 mg |
|---|---|---|---|---|---|
| Age, Customized >=65 years | 14 Participants | 59 Participants | 17 Participants | 16 Participants | 12 Participants |
| Age, Customized Between 18 and 65 years | 88 Participants | 341 Participants | 84 Participants | 83 Participants | 86 Participants |
| Race/Ethnicity, Customized Asian | 19 Participants | 78 Participants | 22 Participants | 18 Participants | 19 Participants |
| Race/Ethnicity, Customized Black | 9 Participants | 33 Participants | 11 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 19 Participants | 63 Participants | 15 Participants | 14 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 226 Participants | 53 Participants | 64 Participants | 54 Participants |
| Sex: Female, Male Female | 7 Participants | 34 Participants | 10 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Male | 95 Participants | 366 Participants | 91 Participants | 90 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 101 | 22 / 99 | 21 / 98 | 32 / 102 |
| serious Total, serious adverse events | 0 / 101 | 0 / 99 | 0 / 98 | 1 / 102 |
Outcome results
Primary
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).
Time frame: Baseline and Day 2
Population: Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline | 3.03 Scores on a scale | Standard Deviation 0.67 |
| Celecoxib 50 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.14 Scores on a scale | Standard Deviation 1.1 |
| Celecoxib 400/200 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.23 Scores on a scale | Standard Deviation 0.97 |
| Celecoxib 400/200 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline | 2.73 Scores on a scale | Standard Deviation 0.62 |
| Celecoxib 800/400 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline | 2.84 Scores on a scale | Standard Deviation 0.69 |
| Celecoxib 800/400 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.51 Scores on a scale | Standard Deviation 1.11 |
| Indomethacin 50 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline | 2.83 Scores on a scale | Standard Deviation 0.76 |
| Indomethacin 50 mg | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.62 Scores on a scale | Standard Deviation 0.97 |
Comparison: This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.95% CI: [-0.74, -0.18]ANCOVA
95% CI: [-0.52, 0.04]ANCOVA
95% CI: [0.29, 0.84]ANCOVA
95% CI: [0.05, 0.6]ANCOVA
95% CI: [-0.17, 0.39]ANCOVA
Secondary
Change From Baseline in Patient's Assessment of Pain Intensity
The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline, Day 2 to Day 13
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 13/Early termination | -1.91 Scores on a scale | Standard Deviation 1.34 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 7 | -1.79 Scores on a scale | Standard Deviation 1.23 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 6 | -1.68 Scores on a scale | Standard Deviation 1.15 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 3 | -1.32 Scores on a scale | Standard Deviation 1.15 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 5 | -1.52 Scores on a scale | Standard Deviation 1.16 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline | 3.03 Scores on a scale | Standard Deviation 0.67 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 12 | -1.93 Scores on a scale | Standard Deviation 1.32 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 11 | -1.89 Scores on a scale | Standard Deviation 1.31 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 10 | -1.90 Scores on a scale | Standard Deviation 1.27 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 1 | -0.65 Scores on a scale | Standard Deviation 0.87 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 4 | -1.52 Scores on a scale | Standard Deviation 1.16 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 9 | -1.86 Scores on a scale | Standard Deviation 1.27 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 8 | -1.88 Scores on a scale | Standard Deviation 1.26 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.14 Scores on a scale | Standard Deviation 1.1 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 10 | -1.99 Scores on a scale | Standard Deviation 1.13 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 4 | -1.60 Scores on a scale | Standard Deviation 0.98 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline | 2.73 Scores on a scale | Standard Deviation 0.62 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 1 | -0.85 Scores on a scale | Standard Deviation 0.86 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.23 Scores on a scale | Standard Deviation 0.97 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 5 | -1.67 Scores on a scale | Standard Deviation 1.04 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 6 | -1.84 Scores on a scale | Standard Deviation 1.05 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 7 | -1.90 Scores on a scale | Standard Deviation 1.16 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 8 | -1.95 Scores on a scale | Standard Deviation 1.12 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 9 | -1.96 Scores on a scale | Standard Deviation 1.12 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 3 | -1.42 Scores on a scale | Standard Deviation 0.98 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 11 | -1.94 Scores on a scale | Standard Deviation 1.13 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 12 | -1.95 Scores on a scale | Standard Deviation 1.18 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 13/Early termination | -1.95 Scores on a scale | Standard Deviation 1.18 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.51 Scores on a scale | Standard Deviation 1.11 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 13/Early termination | -2.27 Scores on a scale | Standard Deviation 1.08 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 7 | -2.29 Scores on a scale | Standard Deviation 1.05 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 12 | -2.27 Scores on a scale | Standard Deviation 1.09 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 8 | -2.30 Scores on a scale | Standard Deviation 0.98 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 1 | -1.06 Scores on a scale | Standard Deviation 1.08 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 9 | -2.24 Scores on a scale | Standard Deviation 1.04 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 3 | -1.78 Scores on a scale | Standard Deviation 1.09 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 10 | -2.23 Scores on a scale | Standard Deviation 1.13 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline | 2.84 Scores on a scale | Standard Deviation 0.69 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 11 | -2.22 Scores on a scale | Standard Deviation 1.15 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 4 | -1.96 Scores on a scale | Standard Deviation 1.08 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 5 | -2.05 Scores on a scale | Standard Deviation 1.1 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 6 | -2.12 Scores on a scale | Standard Deviation 1.06 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 6 | -2.11 Scores on a scale | Standard Deviation 1.01 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 10 | -2.17 Scores on a scale | Standard Deviation 1.01 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 5 | -2.04 Scores on a scale | Standard Deviation 1.03 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 7 | -2.15 Scores on a scale | Standard Deviation 1.02 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 1 | -1.10 Scores on a scale | Standard Deviation 0.92 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 13/Early termination | -1.98 Scores on a scale | Standard Deviation 1.11 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 2 | -1.62 Scores on a scale | Standard Deviation 0.97 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 8 | -2.16 Scores on a scale | Standard Deviation 1.04 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 4 | -2.02 Scores on a scale | Standard Deviation 1 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 12 | -2.07 Scores on a scale | Standard Deviation 1.07 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 3 | -1.84 Scores on a scale | Standard Deviation 0.97 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 9 | -2.19 Scores on a scale | Standard Deviation 1.08 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline | 2.83 Scores on a scale | Standard Deviation 0.76 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity | Change at Day 11 | -2.15 Scores on a scale | Standard Deviation 1.02 |
Comparison: The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.95% CI: [-0.6, -0.1]ANCOVA
Comparison: Day 1 analyses95% CI: [-0.75, -0.25]ANCOVA
Comparison: Day 1 analyses95% CI: [0.29, 0.78]ANCOVA
Comparison: Day 1 analyses95% CI: [-0.06, 0.44]ANCOVA
Comparison: Day 1 analyses95% CI: [-0.21, 0.28]ANCOVA
Comparison: Day 2 analyses95% CI: [-0.52, 0.04]ANCOVA
Comparison: Day 2 analyses95% CI: [-0.74, -0.18]ANCOVA
Comparison: Day 2 analyses95% CI: [0.29, 0.84]ANCOVA
Comparison: Day 2 analyses95% CI: [0.05, 0.6]ANCOVA
Comparison: Day 2 analyses95% CI: [-0.17, 0.39]ANCOVA
Comparison: Day 3 analyses95% CI: [-0.53, 0.03]ANCOVA
Comparison: Day 3 analyses95% CI: [-0.83, -0.26]ANCOVA
Comparison: Day 3 analyses95% CI: [0.32, 0.88]ANCOVA
Comparison: Day 3 analyses95% CI: [0.08, 0.64]ANCOVA
Comparison: Day 3 analyses95% CI: [-0.22, 0.34]ANCOVA
Comparison: Day 4 analyses95% CI: [-0.56, 0]ANCOVA
Comparison: Day 4 analyses95% CI: [-0.84, -0.28]ANCOVA
Comparison: Day 4 analyses95% CI: [0.35, 0.9]ANCOVA
Comparison: Day 4 analyses95% CI: [0.07, 0.62]ANCOVA
Comparison: Day 4 analyses95% CI: [-0.21, 0.34]ANCOVA
Comparison: Day 5 analyses95% CI: [-0.64, -0.07]ANCOVA
Comparison: Day 5 analyses95% CI: [-0.94, -0.38]ANCOVA
Comparison: Day 5 analyses95% CI: [0.37, 0.93]ANCOVA
Comparison: Day 5 analyses95% CI: [0.02, 0.57]ANCOVA
Comparison: Day 5 analyses95% CI: [-0.29, 0.27]ANCOVA
Comparison: Day 6 analyses95% CI: [-0.65, -0.1]ANCOVA
Comparison: Day 6 analyses95% CI: [-0.84, -0.29]ANCOVA
Comparison: Day 6 analyses95% CI: [0.29, 0.83]ANCOVA
Comparison: Day 6 analyses95% CI: [-0.08, 0.46]ANCOVA
Comparison: Day 6 analyses95% CI: [-0.28, 0.26]ANCOVA
Comparison: Day 7 analyses95% CI: [-0.61, -0.04]ANCOVA
Comparison: Day 7 analyses95% CI: [-0.92, -0.34]ANCOVA
Comparison: Day 7 analyses95% CI: [0.21, 0.78]ANCOVA
Comparison: Day 7 analyses95% CI: [-0.11, 0.45]ANCOVA
Comparison: Day 7 analyses95% CI: [-0.42, 0.15]ANCOVA
Comparison: Day 8 analyses95% CI: [-0.57, 0]ANCOVA
Comparison: Day 8 analyses95% CI: [-0.84, -0.27]ANCOVA
Comparison: Day 8 analyses95% CI: [0.14, 0.7]ANCOVA
Comparison: Day 8 analyses95% CI: [-0.15, 0.41]ANCOVA
Comparison: Day 8 analyses95% CI: [-0.42, 0.14]ANCOVA
Comparison: Day 9 analyses95% CI: [-0.61, -0.02]ANCOVA
Comparison: Day 9 analyses95% CI: [-0.82, -0.23]ANCOVA
Comparison: Day 9 analyses95% CI: [0.18, 0.76]ANCOVA
Comparison: Day 9 analyses95% CI: [-0.13, 0.44]ANCOVA
Comparison: Day 9 analyses95% CI: [-0.35, 0.23]ANCOVA
Comparison: Day 10 analyses95% CI: [-0.59, 0.01]ANCOVA
Comparison: Day 10 analyses95% CI: [-0.76, -0.16]ANCOVA
Comparison: Day 10 analyses95% CI: [0.1, 0.69]ANCOVA
Comparison: Day 10 analyses95% CI: [-0.18, 0.41]ANCOVA
Comparison: Day 10 analyses95% CI: [-0.36, 0.23]ANCOVA
Comparison: Day 11 analyses95% CI: [-0.56, 0.05]ANCOVA
Comparison: Day 11 analyses95% CI: [-0.77, -0.17]ANCOVA
Comparison: Day 11 analyses95% CI: [0.1, 0.69]ANCOVA
Comparison: Day 11 analyses95% CI: [-0.16, 0.44]ANCOVA
Comparison: Day 11 analyses95% CI: [-0.37, 0.23]ANCOVA
Comparison: Day 12 analyses95% CI: [-0.53, 0.09]ANCOVA
Comparison: Day 12 analyses95% CI: [-0.77, -0.15]ANCOVA
Comparison: Day 12 analyses95% CI: [-0.04, 0.57]ANCOVA
Comparison: Day 12 analyses95% CI: [-0.25, 0.36]ANCOVA
Comparison: Day 12 analyses95% CI: [-0.5, 0.11]ANCOVA
Comparison: Day 13/Early Termination analyses95% CI: [-0.56, 0.07]ANCOVA
Comparison: Day 13/Early Termination analyses95% CI: [-0.81, -0.19]ANCOVA
Comparison: Day 13/Early Termination analyses95% CI: [-0.1, 0.51]ANCOVA
Comparison: Day 13/Early Termination analyses95% CI: [-0.35, 0.26]ANCOVA
Comparison: Day 13/Early Termination analyses95% CI: [-0.6, 0.01]ANCOVA
Secondary
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).
Time frame: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 12 HR | -0.73 Scores on a scale | Standard Deviation 1.02 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 8 HR | -1.08 Scores on a scale | Standard Deviation 1.07 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 4 HR | -0.53 Scores on a scale | Standard Deviation 0.82 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 2 HR | -0.32 Scores on a scale | Standard Deviation 0.75 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 0 HR | -0.93 Scores on a scale | Standard Deviation 1 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 8 HR | -0.64 Scores on a scale | Standard Deviation 0.92 |
| Celecoxib 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline | 3.03 Scores on a scale | Standard Deviation 0.67 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 8 HR | -0.58 Scores on a scale | Standard Deviation 0.73 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 12 HR | -0.75 Scores on a scale | Standard Deviation 0.79 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 8 HR | -1.07 Scores on a scale | Standard Deviation 0.96 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 2 HR | -0.28 Scores on a scale | Standard Deviation 0.67 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline | 2.73 Scores on a scale | Standard Deviation 0.62 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 4 HR | -0.54 Scores on a scale | Standard Deviation 0.69 |
| Celecoxib 400/200 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 0 HR | -0.98 Scores on a scale | Standard Deviation 0.88 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 4 HR | -0.70 Scores on a scale | Standard Deviation 0.9 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline | 2.84 Scores on a scale | Standard Deviation 0.69 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 2 HR | -0.45 Scores on a scale | Standard Deviation 0.77 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 8 HR | -0.87 Scores on a scale | Standard Deviation 1.05 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 12 HR | -1.02 Scores on a scale | Standard Deviation 1.11 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 0 HR | -1.15 Scores on a scale | Standard Deviation 1.14 |
| Celecoxib 800/400 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 8 HR | -1.31 Scores on a scale | Standard Deviation 1.03 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 4 HR | -0.81 Scores on a scale | Standard Deviation 0.92 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 8 HR | -1.46 Scores on a scale | Standard Deviation 0.93 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 2, 0 HR | -1.26 Scores on a scale | Standard Deviation 0.93 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 2 HR | -0.57 Scores on a scale | Standard Deviation 0.88 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline | 2.83 Scores on a scale | Standard Deviation 0.76 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 12 HR | -1.09 Scores on a scale | Standard Deviation 0.96 |
| Indomethacin 50 mg | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Change at Day 1, 8 HR | -0.98 Scores on a scale | Standard Deviation 0.94 |
Comparison: The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.95% CI: [-0.28, 0.14]ANCOVA
Comparison: Day 1, 2 hours postdose95% CI: [-0.39, 0.03]ANCOVA
Comparison: Day 1, 2 hours postdose95% CI: [0.11, 0.52]ANCOVA
Comparison: Day 1, 2 hours postdose95% CI: [0.04, 0.45]ANCOVA
Comparison: Day 1, 2 hours postdose95% CI: [-0.08, 0.34]ANCOVA
Comparison: Day 1, 4 hours postdose95% CI: [-0.37, 0.08]ANCOVA
Comparison: Day 1, 4 hours postdose95% CI: [-0.48, -0.03]ANCOVA
Comparison: Day 1, 4 hours postdose95% CI: [0.14, 0.58]ANCOVA
Comparison: Day 1, 4 hours postdose95% CI: [0, 0.44]ANCOVA
Comparison: Day 1, 4 hours postdose95% CI: [-0.11, 0.34]ANCOVA
Comparison: Day 1, 8 hours postdose95% CI: [-0.32, 0.17]ANCOVA
Comparison: Day 1, 8 hours postdose95% CI: [-0.56, -0.06]ANCOVA
Comparison: Day 1, 8 hours postdose95% CI: [0.18, 0.67]ANCOVA
Comparison: Day 1, 8 hours postdose95% CI: [0.11, 0.59]ANCOVA
Comparison: Day 1, 8 hours postdose95% CI: [-0.13, 0.36]ANCOVA
Comparison: Day 1, 12 hours postdose95% CI: [-0.42, 0.1]ANCOVA
Comparison: Day 1, 12 hours postdose95% CI: [-0.63, -0.11]ANCOVA
Comparison: Day 1, 12 hours postdose95% CI: [0.19, 0.7]ANCOVA
Comparison: Day 1, 12 hours postdose95% CI: [0.03, 0.55]ANCOVA
Comparison: Day 1, 12 hours postdose95% CI: [-0.18, 0.34]ANCOVA
Comparison: Day 2, 0 hours postdose95% CI: [-0.46, 0.07]ANCOVA
Comparison: Day 2, 0 hours postdose95% CI: [-0.57, -0.04]ANCOVA
Comparison: Day 2, 0 hours postdose95% CI: [0.16, 0.68]ANCOVA
Comparison: Day 2, 0 hours postdose95% CI: [-0.04, 0.49]ANCOVA
Comparison: Day 2, 0 hours postdose95% CI: [-0.15, 0.38]ANCOVA
Comparison: Day 2, 8 hours postdose95% CI: [-0.4, 0.14]ANCOVA
Comparison: Day 2, 8 hours postdose95% CI: [-0.59, -0.05]ANCOVA
Comparison: Day 2, 8 hours postdose95% CI: [0.2, 0.74]ANCOVA
Comparison: Day 2, 8 hours postdose95% CI: [0.08, 0.61]ANCOVA
Comparison: Day 2, 8 hours postdose95% CI: [-0.11, 0.42]ANCOVA
Secondary
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
Time frame: Baseline, Days 5, 9 and 14/Early Termination
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline | 2.16 Scores on a scale | Standard Deviation 0.73 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 5 | -1.22 Scores on a scale | Standard Deviation 1.09 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 9 | -1.47 Scores on a scale | Standard Deviation 1.18 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 14/Early Termination | -1.55 Scores on a scale | Standard Deviation 1.18 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 5 | -1.21 Scores on a scale | Standard Deviation 1.05 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 9 | -1.54 Scores on a scale | Standard Deviation 1 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 14/Early Termination | -1.63 Scores on a scale | Standard Deviation 0.98 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline | 2.08 Scores on a scale | Standard Deviation 0.65 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 9 | -1.62 Scores on a scale | Standard Deviation 0.95 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 5 | -1.27 Scores on a scale | Standard Deviation 0.97 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 14/Early Termination | -1.78 Scores on a scale | Standard Deviation 0.97 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline | 2.09 Scores on a scale | Standard Deviation 0.65 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 14/Early Termination | -1.58 Scores on a scale | Standard Deviation 0.94 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 5 | -1.20 Scores on a scale | Standard Deviation 0.96 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline | 2.01 Scores on a scale | Standard Deviation 0.75 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Change at Day 9 | -1.58 Scores on a scale | Standard Deviation 0.94 |
Comparison: Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.95% CI: [-0.29, 0.22]ANCOVA
Comparison: Day 5 analysis.95% CI: [-0.35, 0.16]ANCOVA
Comparison: Day 5 analysis.95% CI: [-0.17, 0.34]ANCOVA
Comparison: Day 5 analysis.95% CI: [-0.2, 0.3]ANCOVA
Comparison: Day 5 analysis.95% CI: [-0.26, 0.25]ANCOVA
Comparison: Day 9 analysis.95% CI: [-0.36, 0.11]ANCOVA
Comparison: Day 9 analysis.95% CI: [-0.44, 0.04]ANCOVA
Comparison: Day 9 analysis.95% CI: [-0.01, 0.46]ANCOVA
Comparison: Day 9 analysis.95% CI: [-0.14, 0.33]ANCOVA
Comparison: Day 9 analysis.95% CI: [-0.22, 0.26]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.38, 0.1]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.52, -0.04]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.08, 0.39]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.22, 0.26]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.36, 0.12]ANCOVA
Secondary
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).
Time frame: Baseline, Day 5, Day 9, and Day 14/Early Termination
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline | 2.39 Scores on a scale | Standard Deviation 0.72 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 14/Early Termination | -1.74 Scores on a scale | Standard Deviation 1.09 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 5 | -1.44 Scores on a scale | Standard Deviation 0.96 |
| Celecoxib 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 9 | -1.75 Scores on a scale | Standard Deviation 0.98 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 9 | -1.64 Scores on a scale | Standard Deviation 0.93 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 14/Early Termination | -1.66 Scores on a scale | Standard Deviation 1.01 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline | 2.15 Scores on a scale | Standard Deviation 0.75 |
| Celecoxib 400/200 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 5 | -1.39 Scores on a scale | Standard Deviation 0.89 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline | 2.26 Scores on a scale | Standard Deviation 0.65 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 14/Early Termination | -1.94 Scores on a scale | Standard Deviation 0.88 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 5 | -1.58 Scores on a scale | Standard Deviation 0.93 |
| Celecoxib 800/400 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 9 | -1.84 Scores on a scale | Standard Deviation 0.92 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 14/Early Termination | -1.64 Scores on a scale | Standard Deviation 0.93 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 9 | -1.65 Scores on a scale | Standard Deviation 0.87 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline | 2.13 Scores on a scale | Standard Deviation 0.7 |
| Indomethacin 50 mg | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Change at Day 5 | -1.52 Scores on a scale | Standard Deviation 0.86 |
Comparison: Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.95% CI: [-0.29, 0.14]ANCOVA
Comparison: Day 5 analysis95% CI: [-0.42, 0.02]ANCOVA
Comparison: Day 5 analysis95% CI: [0.04, 0.47]ANCOVA
Comparison: Day 5 analysis95% CI: [-0.04, 0.39]ANCOVA
Comparison: Day 5 analysis95% CI: [-0.16, 0.27]ANCOVA
Comparison: Day 9 analysis95% CI: [-0.26, 0.16]ANCOVA
Comparison: Day 9 analysis95% CI: [-0.4, 0.03]ANCOVA
Comparison: Day 9 analysis95% CI: [-0.11, 0.32]ANCOVA
Comparison: Day 9 analysis95% CI: [-0.16, 0.27]ANCOVA
Comparison: Day 9 analysis95% CI: [-0.3, 0.13]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.33, 0.1]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.53, -0.11]ANCOVA
Comparison: Day /early termination analysis95% CI: [-0.05, 0.37]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.17, 0.25]ANCOVA
Comparison: Day 14/early termination analysis95% CI: [-0.38, 0.05]ANCOVA
Secondary
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity
Time frame: Baseline, 8, 12, and 24 hours post first dose
Population: ITT and LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline | 3.03 Scores on a scale | Standard Deviation 0.67 |
| Celecoxib 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 8 HR | 0.44 Scores on a scale | Standard Deviation 0.66 |
| Celecoxib 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 12 HR | 0.52 Scores on a scale | Standard Deviation 0.73 |
| Celecoxib 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 24 HR | 0.67 Scores on a scale | Standard Deviation 0.81 |
| Celecoxib 400/200 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 8 HR | 0.42 Scores on a scale | Standard Deviation 0.55 |
| Celecoxib 400/200 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 12 HR | 0.50 Scores on a scale | Standard Deviation 0.58 |
| Celecoxib 400/200 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 24 HR | 0.68 Scores on a scale | Standard Deviation 0.66 |
| Celecoxib 400/200 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline | 2.73 Scores on a scale | Standard Deviation 0.62 |
| Celecoxib 800/400 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 12 HR | 0.71 Scores on a scale | Standard Deviation 0.82 |
| Celecoxib 800/400 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 8 HR | 0.59 Scores on a scale | Standard Deviation 0.74 |
| Celecoxib 800/400 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 24 HR | 0.89 Scores on a scale | Standard Deviation 0.93 |
| Celecoxib 800/400 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline | 2.84 Scores on a scale | Standard Deviation 0.69 |
| Indomethacin 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 24 HR | 0.99 Scores on a scale | Standard Deviation 0.82 |
| Indomethacin 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 8 HR | 0.69 Scores on a scale | Standard Deviation 0.75 |
| Indomethacin 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline | 2.83 Scores on a scale | Standard Deviation 0.76 |
| Indomethacin 50 mg | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Change at 12 HR | 0.81 Scores on a scale | Standard Deviation 0.79 |
Comparison: 12 hour postdose analysis95% CI: [-0.1, 0.29]ANCOVA
Comparison: 8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.95% CI: [-0.09, 0.27]ANCOVA
Comparison: 8 hour postdose analysis95% CI: [0.04, 0.4]ANCOVA
Comparison: 8 hour postdose analysis95% CI: [-0.5, -0.14]ANCOVA
Comparison: 8 hour postdose analysis95% CI: [-0.41, -0.05]ANCOVA
Comparison: 8 hour postdose analysis95% CI: [-0.28, 0.08]ANCOVA
Comparison: 12 hour postdose analysis95% CI: [0.06, 0.45]ANCOVA
Comparison: 12 hour postdose analysis95% CI: [-0.55, -0.16]ANCOVA
Comparison: 12 hour postdose analysis95% CI: [-0.45, -0.07]ANCOVA
Comparison: 12 hour postdose analysis95% CI: [-0.29, 0.09]ANCOVA
Comparison: 24 hour postdose analysis95% CI: [-0.08, 0.35]ANCOVA
Comparison: 24 hour postdose analysis95% CI: [0.08, 0.51]ANCOVA
Comparison: 24 hour postdose analysis95% CI: [-0.61, -0.18]ANCOVA
Comparison: 24 hour postdose analysis95% CI: [-0.47, -0.05]ANCOVA
Comparison: 24 hour postdose analysis95% CI: [-0.32, 0.11]ANCOVA
Secondary
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline, Day 2
Population: ITT and LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 50 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 30% | 58 Participants |
| Celecoxib 50 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 50% | 43 Participants |
| Celecoxib 400/200 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 50% | 57 Participants |
| Celecoxib 400/200 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 30% | 69 Participants |
| Celecoxib 800/400 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 30% | 75 Participants |
| Celecoxib 800/400 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 50% | 63 Participants |
| Indomethacin 50 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 30% | 82 Participants |
| Indomethacin 50 mg | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Reduction in Pain Intensity >= 50% | 71 Participants |
Comparison: \>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.p-value: 0.0459Cochran-Mantel-Haenszel
Comparison: \>=30% reduction analysesp-value: 0.0017Cochran-Mantel-Haenszel
Comparison: \>=30% reduction analysesp-value: 0.0001Cochran-Mantel-Haenszel
Comparison: \>=30% reduction analysesp-value: 0.041Cochran-Mantel-Haenszel
Comparison: \>=30% reduction analysesp-value: 0.5592Cochran-Mantel-Haenszel
Comparison: \>=50% reduction analysesp-value: 0.0277Cochran-Mantel-Haenszel
Comparison: \>=50% reduction analysesp-value: 0.0018Cochran-Mantel-Haenszel
Comparison: \>=50% reduction analysesp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: \>=50% reduction analysesp-value: 0.0394Cochran-Mantel-Haenszel
Comparison: \>=50% reduction analysesp-value: 0.4603Cochran-Mantel-Haenszel
Secondary
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Time frame: Baseline to Day 14/Early Termination
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 50 mg | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | 3 Participants |
| Celecoxib 400/200 mg | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | 2 Participants |
| Celecoxib 800/400 mg | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | 1 Participants |
| Indomethacin 50 mg | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | 5 Participants |
Comparison: p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.p-value: 0.4724Cochran-Mantel-Haenszel
Comparison: p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.p-value: 0.7316Cochran-Mantel-Haenszel
Comparison: p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.p-value: 0.7316Cochran-Mantel-Haenszel
Secondary
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)
Time frame: Baseline to Day 14/Early Termination
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 50 mg | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | 1 Participants |
| Celecoxib 400/200 mg | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | 0 Participants |
| Celecoxib 800/400 mg | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | 2 Participants |
| Indomethacin 50 mg | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | 3 Participants |
Comparison: p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.p-value: 0.3173Cochran-Mantel-Haenszel
Secondary
Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination
Redness was assessed by the physician as present or absent.
Time frame: Baseline, Day 5, Day 9 and Day 14/Early Termination
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline | 84 Participants |
| Celecoxib 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 5 | 27 Participants |
| Celecoxib 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 9 | 12 Participants |
| Celecoxib 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 14/Early termination | 15 Participants |
| Celecoxib 400/200 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 14/Early termination | 15 Participants |
| Celecoxib 400/200 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 9 | 15 Participants |
| Celecoxib 400/200 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 5 | 29 Participants |
| Celecoxib 400/200 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline | 88 Participants |
| Celecoxib 800/400 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 9 | 13 Participants |
| Celecoxib 800/400 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 14/Early termination | 7 Participants |
| Celecoxib 800/400 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 5 | 26 Participants |
| Celecoxib 800/400 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline | 79 Participants |
| Indomethacin 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 14/Early termination | 13 Participants |
| Indomethacin 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline | 85 Participants |
| Indomethacin 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 5 | 23 Participants |
| Indomethacin 50 mg | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Day 9 | 11 Participants |
Comparison: Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.6402Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.9739Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.4581Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.2962Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.4951Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.4957Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.8364Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.6892Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.411Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.5981Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.9317Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.0831Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.5747Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.6204Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysisp-value: 0.2556Cochran-Mantel-Haenszel
Secondary
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Warmth was assessed by the physician as present or absent.
Time frame: Baseline, Day 5, Day 9 and Day 14
Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline | 89 Participants |
| Celecoxib 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 5 | 25 Participants |
| Celecoxib 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 9 | 13 Participants |
| Celecoxib 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | DAY 14/E_TERM | 19 Participants |
| Celecoxib 400/200 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 5 | 16 Participants |
| Celecoxib 400/200 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 9 | 8 Participants |
| Celecoxib 400/200 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | DAY 14/E_TERM | 7 Participants |
| Celecoxib 400/200 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline | 91 Participants |
| Celecoxib 800/400 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 9 | 9 Participants |
| Celecoxib 800/400 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 5 | 22 Participants |
| Celecoxib 800/400 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | DAY 14/E_TERM | 11 Participants |
| Celecoxib 800/400 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline | 91 Participants |
| Indomethacin 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | DAY 14/E_TERM | 15 Participants |
| Indomethacin 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 5 | 21 Participants |
| Indomethacin 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline | 88 Participants |
| Indomethacin 50 mg | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Day 9 | 11 Participants |
Comparison: Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.1444Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.7532Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.4722Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.3878Cochran-Mantel-Haenszel
Comparison: Day 5 analysesp-value: 0.6717Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.3098Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.4356Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.5703Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.4986Cochran-Mantel-Haenszel
Comparison: Day 9 analysesp-value: 0.7855Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.0169Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.1353Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.369Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.0787Cochran-Mantel-Haenszel
Comparison: Day 14/Early Termination analysesp-value: 0.5687Cochran-Mantel-Haenszel
Secondary
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Time frame: Day 1 to Day 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 | 2 Participants |
| Celecoxib 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during study | 11 Participants |
| Celecoxib 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during treatment | 10 Participants |
| Celecoxib 400/200 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 | 1 Participants |
| Celecoxib 400/200 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during study | 9 Participants |
| Celecoxib 400/200 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during treatment | 8 Participants |
| Celecoxib 800/400 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during treatment | 4 Participants |
| Celecoxib 800/400 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 | 0 Participants |
| Celecoxib 800/400 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during study | 5 Participants |
| Indomethacin 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 | 0 Participants |
| Indomethacin 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during study | 4 Participants |
| Indomethacin 50 mg | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Any time during treatment | 3 Participants |
Comparison: Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.5528Cochran-Mantel-Haenszel
Comparison: Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.1779Cochran-Mantel-Haenszel
Comparison: Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.1754Cochran-Mantel-Haenszel
Comparison: Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.3384Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.5005Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.0845Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.0213Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.1231Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.6636Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.5378Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.0818Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.0317Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.1592Cochran-Mantel-Haenszel
Comparison: Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.p-value: 0.7956Cochran-Mantel-Haenszel
Secondary
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time frame: Baseline
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 50 mg | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | 3.03 Units on a scale | Standard Deviation 0.67 |
| Celecoxib 400/200 mg | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | 2.73 Units on a scale | Standard Deviation 0.62 |
| Celecoxib 800/400 mg | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | 2.84 Units on a scale | Standard Deviation 0.69 |
| Indomethacin 50 mg | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | 2.83 Units on a scale | Standard Deviation 0.76 |
Secondary
Participants Global Evaluation of Study Medication Score
The participant rated the study medication that they received during the study by completing the following question: How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor
Time frame: Day 9
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 50 mg | Participants Global Evaluation of Study Medication Score | 3.04 Scores on a scale | Standard Deviation 0.87 |
| Celecoxib 400/200 mg | Participants Global Evaluation of Study Medication Score | 3.11 Scores on a scale | Standard Deviation 0.85 |
| Celecoxib 800/400 mg | Participants Global Evaluation of Study Medication Score | 3.27 Scores on a scale | Standard Deviation 0.69 |
| Indomethacin 50 mg | Participants Global Evaluation of Study Medication Score | 3.33 Scores on a scale | Standard Deviation 0.75 |
Comparison: The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.95% CI: [-0.17, 0.31]ANCOVA
95% CI: [-0.02, 0.46]ANCOVA
95% CI: [-0.5, -0.02]ANCOVA
95% CI: [-0.43, 0.05]ANCOVA
95% CI: [-0.28, 0.19]ANCOVA
Secondary
Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13
The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.
Time frame: Baseline to Day 13
Population: ITT, LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 4 | -44.13 Percentage change | Standard Deviation 36.66 |
| Celecoxib 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 13 | -56.11 Percentage change | Standard Deviation 36.47 |
| Celecoxib 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 8 | -51.36 Percentage change | Standard Deviation 35.57 |
| Celecoxib 400/200 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 4 | -53.15 Percentage change | Standard Deviation 34.17 |
| Celecoxib 400/200 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 13 | -66.26 Percentage change | Standard Deviation 35.55 |
| Celecoxib 400/200 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 8 | -61.83 Percentage change | Standard Deviation 34.68 |
| Celecoxib 800/400 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 8 | -69.41 Percentage change | Standard Deviation 30.86 |
| Celecoxib 800/400 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 4 | -60.11 Percentage change | Standard Deviation 33.57 |
| Celecoxib 800/400 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 13 | -73.59 Percentage change | Standard Deviation 29.74 |
| Indomethacin 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 4 | 2.83 Percentage change | Standard Deviation 0.76 |
| Indomethacin 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 13 | -72.35 Percentage change | Standard Deviation 27.39 |
| Indomethacin 50 mg | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Average change over days 2 - 8 | -70.05 Percentage change | Standard Deviation 27.45 |