Osteoarthritis
Conditions
Keywords
GI events in patients with moderate GI risk treated with NSAIDS
Brief summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Interventions
DRUGCelecoxib
open-label
DRUGAny commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.
Exclusion criteria
* GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit. * Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | Baseline through week 24 or Early Termination (ET) | CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematocrit (Hct) at Baseline | Baseline | — |
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Baseline, Weeks 8, 16, 24 or ET | Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15. |
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Baseline, Weeks 8, 16, 24 or ET | Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15. |
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Baseline, Weeks 8, 16, 24 or ET | Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15. |
| Percentage of Participants With Moderate to Severe Abdominal Symptoms | Baseline through week 24 or ET | Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function. |
| Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) | Baseline through week 24 or ET | GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions |
| Hemoglobin (Hb) at Baseline | Baseline | — |
| Change From Baseline Hb at Week 24 | Baseline and Week 24 or ET | — |
| Change From Baseline Hct at Week 24 | Baseline and Week 24 or ET | — |
| Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Baseline, Weeks 8, 16, 24 or ET | Clinically significant decrease in Hct (greater than or equal to 10 percent \[≥10%\]) and/or decrease in Hb (≥ 2 g/dL). |
| Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Baseline, Weeks 8, 16, 24 or ET | Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-study Medication Utilization | Baseline through week 24 or ET | Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use. |
| Percentage of Participants With Positive Blood Fecal Occult | Week 24 or ET | Positive blood fecal occult; blood in feces that is not visibly apparent |
| Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | Baseline through week 24 or ET | PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists \[H2RA\], misoprostol, sucralfate, and others such as antacids) utilization. |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
A total of 8140 participants were randomized into the trial, however the final analysis was on 8067 participants because 35 participants were randomized twice and 1 participant was randomized 3 times, totaling 73.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Celecoxib open-label per United States Package Insert (US PI) recommended dosing | 4,035 |
| nsNSAIDs Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing | 4,032 |
| Total | 8,067 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 278 | 253 |
| Overall Study | Death | 2 | 1 |
| Overall Study | Did not meet entrance criteria | 167 | 184 |
| Overall Study | Final Status Unknown | 12 | 4 |
| Overall Study | Insufficient clinical response | 169 | 119 |
| Overall Study | Lost to follow up | 83 | 103 |
| Overall Study | No longer willing to participate | 337 | 352 |
| Overall Study | Other | 149 | 146 |
| Overall Study | Protocol Violation | 191 | 182 |
| Overall Study | Randomized, not treated | 51 | 77 |
Baseline characteristics
| Characteristic | Celecoxib | nsNSAIDs | Total |
|---|---|---|---|
| Age, Customized 55-59 years | 1339 Participants | 1361 Participants | 2700 Participants |
| Age, Customized <55 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Customized 60-64 years | 1149 Participants | 1127 Participants | 2276 Participants |
| Age, Customized 65-69 years | 848 Participants | 822 Participants | 1670 Participants |
| Age, Customized 70-74 years | 504 Participants | 517 Participants | 1021 Participants |
| Age, Customized >=75 years | 184 Participants | 197 Participants | 381 Participants |
| Age, Customized Unspecified | 6 Participants | 6 Participants | 12 Participants |
| Sex/Gender, Customized Female | 3049 Participants | 3064 Participants | 6113 Participants |
| Sex/Gender, Customized Male | 980 Participants | 962 Participants | 1942 Participants |
| Sex/Gender, Customized Unspecified | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 962 / 3,970 | 1,163 / 3,951 |
| serious Total, serious adverse events | 99 / 3,970 | 95 / 3,951 |
Outcome results
Primary
Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.
Time frame: Baseline through week 24 or Early Termination (ET)
Population: Intent-to-Treat (ITT) Population: randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 1.3 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) | 2.4 Percentage of participants |
p-value: 0.0003Life Table Extension of CMH Test
Secondary
Change From Baseline Hb at Week 24
Time frame: Baseline and Week 24 or ET
Population: ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline Hb at Week 24 | -0.109 g/dL | Standard Error 0.012 |
| nsNSAIDs | Change From Baseline Hb at Week 24 | -0.241 g/dL | Standard Error 0.012 |
p-value: <0.0001ANCOVA
Secondary
Change From Baseline Hct at Week 24
Time frame: Baseline and Week 24 or ET
Population: ITT; N= number of evaluable participants analyzed; LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline Hct at Week 24 | -0.330 Percent | Standard Error 0.038 |
| nsNSAIDs | Change From Baseline Hct at Week 24 | -0.716 Percent | Standard Error 0.039 |
p-value: <0.0001ANCOVA
Secondary
Hematocrit (Hct) at Baseline
Time frame: Baseline
Population: ITT; N= number of evaluable participants analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Hematocrit (Hct) at Baseline | 40.8 Percent | Standard Deviation 3.4 |
| nsNSAIDs | Hematocrit (Hct) at Baseline | 40.9 Percent | Standard Deviation 3.4 |
Secondary
Hemoglobin (Hb) at Baseline
Time frame: Baseline
Population: ITT; N= number of evaluable participants analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Hemoglobin (Hb) at Baseline | 13.6 gram per deciliter (g/dL) | Standard Deviation 1.1 |
| nsNSAIDs | Hemoglobin (Hb) at Baseline | 13.6 gram per deciliter (g/dL) | Standard Deviation 1.2 |
Secondary
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief
Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.
Time frame: Baseline, Weeks 8, 16, 24 or ET
Population: ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 8 (n=3185, 3203) | 77.4 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 24 or ET (n=3385, 3362) | 74.0 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 16 (n=2783, 2778) | 80.5 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 24/LOCF (n=3671, 3653) | 74.0 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Baseline (n=3888, 3905) | 41.4 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 24/LOCF (n=3671, 3653) | 70.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Baseline (n=3888, 3905) | 40.5 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 8 (n=3185, 3203) | 69.2 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 16 (n=2783, 2778) | 74.5 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief | Week 24 or ET (n=3385, 3362) | 71.3 Percentage of participants |
Comparison: Baselinep-value: 0.4074Chi-squared
Comparison: Week 8p-value: <0.0001Chi-squared
Comparison: Week 16p-value: <0.0001Chi-squared
Comparison: Week 24 or ETp-value: 0.0127Chi-squared
Comparison: Week 24/LOCFp-value: 0.0019Chi-squared
Secondary
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief
Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.
Time frame: Baseline, Weeks 8, 16, 24 or ET
Population: ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 8 (n=3182, 3202) | 75.4 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 24 or ET (n=3383,3361) | 72.2 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 16 (n=2780,2778) | 77.8 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 24/LOCF (n=3671, 3653) | 72.2 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Baseline (n=3886, 3905) | 37.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 24/LOCF (n=3671, 3653) | 68.2 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Baseline (n=3886, 3905) | 36.6 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 8 (n=3182, 3202) | 66.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 16 (n=2780,2778) | 71.6 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief | Week 24 or ET (n=3383,3361) | 68.8 Percentage of participants |
Comparison: Baselinep-value: 0.2699Chi-squared
Comparison: Week 8p-value: <0.0001Chi-squared
Comparison: Week 16p-value: <0.0001Chi-squared
Comparison: Week 24 or ETp-value: 0.0027Chi-squared
Comparison: Week 24/LOCFp-value: 0.0001Chi-squared
Secondary
Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall
Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).
Time frame: Baseline, Weeks 8, 16, 24 or ET
Population: ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 8 (n=3181, 3199) | 78.5 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 24 or ET (n=3383, 3361) | 74.6 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 16 (n=2784, 2772) | 81.9 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 24/LOCF (n=3672, 3651) | 74.5 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Baseline (n=3887, 3904) | 39.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 24/LOCF (n=3672, 3651) | 70.3 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Baseline (n=3887, 3904) | 38.0 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 8 (n=3181, 3199) | 69.5 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 16 (n=2784, 2772) | 74.6 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall | Week 24 or ET (n=3383, 3361) | 70.8 Percentage of participants |
Comparison: Baselinep-value: 0.1008Chi-squared
Comparison: Week 8p-value: <0.0001Chi-squared
Comparison: Week 16p-value: <0.0001Chi-squared
Comparison: Week 24 or ETp-value: 0.0005Chi-squared
Comparison: Week 24/LOCFp-value: <0.0001Chi-squared
Secondary
Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief
Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.
Time frame: Baseline, Weeks 8, 16, 24 or ET
Population: ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 8 (n=3185, 3202) | 80.2 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 24 or ET (n=3386,3362) | 76.2 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 16 (n=2784,2777) | 83.2 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 24/LOCF (n=3672, 3653) | 76.0 Percentage of participants |
| Celecoxib | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Baseline (n=3890, 3905) | 43.2 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 24/LOCF (n=3672, 3653) | 73.3 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Baseline (n=3890, 3905) | 43.7 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 8 (n=3185, 3202) | 71.6 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 16 (n=2784,2777) | 77.7 Percentage of participants |
| nsNSAIDs | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief | Week 24 or ET (n=3386,3362) | 73.8 Percentage of participants |
Comparison: Baselinep-value: 0.6562Chi-squared
Comparison: Week 8p-value: <0.0001Chi-squared
Comparison: Week 16p-value: <0.0001Chi-squared
Comparison: Week 24 or ETp-value: 0.0245Chi-squared
Comparison: Week 24/LOCFp-value: 0.0074Chi-squared
Secondary
Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)
GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions
Time frame: Baseline through week 24 or ET
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) | 2.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) | 3.0 Percentage of participants |
p-value: 0.614Life Table Extension of CMH Test
Secondary
Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline
Clinically significant decrease in Hct (greater than or equal to 10 percent \[≥10%\]) and/or decrease in Hb (≥ 2 g/dL).
Time frame: Baseline, Weeks 8, 16, 24 or ET
Population: ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 8 (n= 3043, 3086) | 0.7 Percentage of participants |
| Celecoxib | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 16 (n=2687, 2675) | 0.8 Percentage of participants |
| Celecoxib | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 24 (n=3278, 3207) | 0.9 Percentage of participants |
| Celecoxib | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 24 LOCF (n=3604, 3574) | 1.8 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 24 LOCF (n=3604, 3574) | 2.9 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 8 (n= 3043, 3086) | 0.9 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 24 (n=3278, 3207) | 1.5 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline | Week 16 (n=2687, 2675) | 1.6 Percentage of participants |
p-value: 0.0023Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Moderate to Severe Abdominal Symptoms
Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.
Time frame: Baseline through week 24 or ET
Population: ITT;
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Percentage of Participants With Moderate to Severe Abdominal Symptoms | 2.3 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Moderate to Severe Abdominal Symptoms | 3.4 Percentage of participants |
p-value: 0.0035Life Table Extension of CMH Test
Other Pre-specified
Percentage of Participants With Non-study Medication Utilization
Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.
Time frame: Baseline through week 24 or ET
Population: ITT; N= number of evaluable participants analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants With Non-study Medication Utilization | Acetaminophen | 6.8 Percentage of participants |
| Celecoxib | Percentage of Participants With Non-study Medication Utilization | Acetylsalicylic acid (ASA) | 3.5 Percentage of participants |
| Celecoxib | Percentage of Participants With Non-study Medication Utilization | NSAIDs | 12.8 Percentage of participants |
| Celecoxib | Percentage of Participants With Non-study Medication Utilization | Opioids | 14.2 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Non-study Medication Utilization | Opioids | 15.6 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Non-study Medication Utilization | Acetaminophen | 6.5 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Non-study Medication Utilization | NSAIDs | 13.3 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Non-study Medication Utilization | Acetylsalicylic acid (ASA) | 3.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Positive Blood Fecal Occult
Positive blood fecal occult; blood in feces that is not visibly apparent
Time frame: Week 24 or ET
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Percentage of Participants With Positive Blood Fecal Occult | 1.1 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Positive Blood Fecal Occult | 1.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization
PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists \[H2RA\], misoprostol, sucralfate, and others such as antacids) utilization.
Time frame: Baseline through week 24 or ET
Population: ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | PPIs | 23.0 Percentage of participants |
| Celecoxib | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | H2RAs | 5.0 Percentage of participants |
| Celecoxib | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | Gastric protective agents | 0.9 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | PPIs | 24.2 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | H2RAs | 5.7 Percentage of participants |
| nsNSAIDs | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization | Gastric protective agents | 1.0 Percentage of participants |