GI-REASONS: GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00373685
Collaborator
(none)
8,067
777
2
49
10.4
0.2
Study Details
Study Description
Brief Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
8067 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients
Study Start Date
:
Oct 1, 2006
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Celecoxib dosing as per USPI label |
Drug: Celecoxib
open-label
|
| Active Comparator: NSAIDs
|
Drug: Any commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- Hematocrit (Hct) at Baseline [Baseline]
- 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).
- 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.
Other Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Abbeville | Alabama | United States | 36310 |
| 2 | Pfizer Investigational Site | Alexander City | Alabama | United States | 35010 |
| 3 | Pfizer Investigational Site | Bay Minette | Alabama | United States | 36507-4185 |
| 4 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35205 |
| 5 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35209 |
| 6 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35215 |
| 7 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35218 |
| 8 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35235 |
| 9 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35244 |
| 10 | Pfizer Investigational Site | Cullman | Alabama | United States | 35058 |
| 11 | Pfizer Investigational Site | Dothan | Alabama | United States | 36301 |
| 12 | Pfizer Investigational Site | Dothan | Alabama | United States | 36303 |
| 13 | Pfizer Investigational Site | Geneva | Alabama | United States | 36340 |
| 14 | Pfizer Investigational Site | Gulf Shores | Alabama | United States | 36547 |
| 15 | Pfizer Investigational Site | Guntersville | Alabama | United States | 35976 |
| 16 | Pfizer Investigational Site | Huntsville | Alabama | United States | 35801 |
| 17 | Pfizer Investigational Site | Huntsville | Alabama | United States | 35824 |
| 18 | Pfizer Investigational Site | Jacksonville | Alabama | United States | 36265 |
| 19 | Pfizer Investigational Site | Mobile | Alabama | United States | 36604-1416 |
| 20 | Pfizer Investigational Site | Montgomery | Alabama | United States | 36106 |
| 21 | Pfizer Investigational Site | Muscle Shoals | Alabama | United States | 35662 |
| 22 | Pfizer Investigational Site | Ozark | Alabama | United States | 36360 |
| 23 | Pfizer Investigational Site | Pell City | Alabama | United States | 32515 |
| 24 | Pfizer Investigational Site | Tallassee | Alabama | United States | 36078 |
| 25 | Pfizer Investigational Site | Chandler | Arizona | United States | 85224 |
| 26 | Pfizer Investigational Site | Glendale | Arizona | United States | 85308 |
| 27 | Pfizer Investigational Site | Green Valley | Arizona | United States | 85614 |
| 28 | Pfizer Investigational Site | Mesa | Arizona | United States | 85203 |
| 29 | Pfizer Investigational Site | Mesa | Arizona | United States | 85206 |
| 30 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85016 |
| 31 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85023 |
| 32 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85028 |
| 33 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85032 |
| 34 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85051 |
| 35 | Pfizer Investigational Site | Scottsdale | Arizona | United States | 85258 |
| 36 | Pfizer Investigational Site | Sierra Vista | Arizona | United States | 85635 |
| 37 | Pfizer Investigational Site | Sun Lakes | Arizona | United States | 85248 |
| 38 | Pfizer Investigational Site | Tempe | Arizona | United States | 85282 |
| 39 | Pfizer Investigational Site | Tempe | Arizona | United States | 85283 |
| 40 | Pfizer Investigational Site | Tucson | Arizona | United States | 85712 |
| 41 | Pfizer Investigational Site | Tucson | Arizona | United States | 85719 |
| 42 | Pfizer Investigational Site | Hot Springs | Arkansas | United States | 71913 |
| 43 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 44 | Pfizer Investigational Site | Paragould | Arkansas | United States | 72450 |
| 45 | Pfizer Investigational Site | Pine Bluff | Arkansas | United States | 71603 |
| 46 | Pfizer Investigational Site | Anaheim | California | United States | 92801 |
| 47 | Pfizer Investigational Site | Anaheim | California | United States | 92804 |
| 48 | Pfizer Investigational Site | Bakersfield | California | United States | 93309 |
| 49 | Pfizer Investigational Site | Bellflower | California | United States | 90706 |
| 50 | Pfizer Investigational Site | Bermuda Dunes | California | United States | 92203 |
| 51 | Pfizer Investigational Site | Buena Park | California | United States | 90620-3886 |
| 52 | Pfizer Investigational Site | Buena Park | California | United States | 90620 |
| 53 | Pfizer Investigational Site | Carson | California | United States | 90745 |
| 54 | Pfizer Investigational Site | Cerritos | California | United States | 90703 |
| 55 | Pfizer Investigational Site | Chula Vista | California | United States | 91910 |
| 56 | Pfizer Investigational Site | Cudahy | California | United States | 90201 |
| 57 | Pfizer Investigational Site | El Cajon | California | United States | 92019 |
| 58 | Pfizer Investigational Site | El Segundo | California | United States | 90245 |
| 59 | Pfizer Investigational Site | Encino | California | United States | 91436 |
| 60 | Pfizer Investigational Site | Escondido | California | United States | 92025-3406 |
| 61 | Pfizer Investigational Site | Fortuna | California | United States | 95540 |
| 62 | Pfizer Investigational Site | Fremont | California | United States | 94536 |
| 63 | Pfizer Investigational Site | Fresno | California | United States | 93710 |
| 64 | Pfizer Investigational Site | Fresno | California | United States | 93726 |
| 65 | Pfizer Investigational Site | Garden Grove | California | United States | 92843 |
| 66 | Pfizer Investigational Site | Garden Grove | California | United States | 92845 |
| 67 | Pfizer Investigational Site | Greenbrae | California | United States | 94904 |
| 68 | Pfizer Investigational Site | Harbor City | California | United States | 90710 |
| 69 | Pfizer Investigational Site | Hemet | California | United States | 92543 |
| 70 | Pfizer Investigational Site | Huntington Beach | California | United States | 92646 |
| 71 | Pfizer Investigational Site | Huntington Park | California | United States | 90255 |
| 72 | Pfizer Investigational Site | Irvine | California | United States | 92618 |
| 73 | Pfizer Investigational Site | La Jolla | California | United States | 92037-1233 |
| 74 | Pfizer Investigational Site | La Palma | California | United States | 90623 |
| 75 | Pfizer Investigational Site | Long Beach | California | United States | 90806 |
| 76 | Pfizer Investigational Site | Long Beach | California | United States | 90807 |
| 77 | Pfizer Investigational Site | Long Beach | California | United States | 90813 |
| 78 | Pfizer Investigational Site | Los Angeles | California | United States | 90017 |
| 79 | Pfizer Investigational Site | Los Angeles | California | United States | 90025 |
| 80 | Pfizer Investigational Site | Los Angeles | California | United States | 90026 |
| 81 | Pfizer Investigational Site | Los Angeles | California | United States | 90041-2321 |
| 82 | Pfizer Investigational Site | Los Banos | California | United States | 93635 |
| 83 | Pfizer Investigational Site | Los Gatos | California | United States | 95032 |
| 84 | Pfizer Investigational Site | Marina Del Rey | California | United States | 90292-5425 |
| 85 | Pfizer Investigational Site | Merced | California | United States | 95340 |
| 86 | Pfizer Investigational Site | Mission Viejo | California | United States | 92691 |
| 87 | Pfizer Investigational Site | Montebello | California | United States | 90640 |
| 88 | Pfizer Investigational Site | Monterey Park | California | United States | 91754 |
| 89 | Pfizer Investigational Site | Newport Beach | California | United States | 92260 |
| 90 | Pfizer Investigational Site | Newport Beach | California | United States | 92660 |
| 91 | Pfizer Investigational Site | Paramount | California | United States | 90723 |
| 92 | Pfizer Investigational Site | Pismo Beach | California | United States | 93449 |
| 93 | Pfizer Investigational Site | Rancho Cucamonga | California | United States | 91730 |
| 94 | Pfizer Investigational Site | Redlands | California | United States | 92374 |
| 95 | Pfizer Investigational Site | Reseda | California | United States | 91335 |
| 96 | Pfizer Investigational Site | Rialto | California | United States | 92376 |
| 97 | Pfizer Investigational Site | Riverside | California | United States | 92506 |
| 98 | Pfizer Investigational Site | Rowland Heights | California | United States | 91748 |
| 99 | Pfizer Investigational Site | Sacramento | California | United States | 95823 |
| 100 | Pfizer Investigational Site | San Diego | California | United States | 92101 |
| 101 | Pfizer Investigational Site | San Diego | California | United States | 92108 |
| 102 | Pfizer Investigational Site | San Diego | California | United States | 92117 |
| 103 | Pfizer Investigational Site | San Diego | California | United States | 92120 |
| 104 | Pfizer Investigational Site | San Francisco | California | United States | 94109 |
| 105 | Pfizer Investigational Site | San Jose | California | United States | 95112 |
| 106 | Pfizer Investigational Site | San Leandro | California | United States | 94578 |
| 107 | Pfizer Investigational Site | Santa Ana | California | United States | 92701 |
| 108 | Pfizer Investigational Site | Santa Ana | California | United States | 92704 |
| 109 | Pfizer Investigational Site | Santa Maria | California | United States | 93454 |
| 110 | Pfizer Investigational Site | Tarzana | California | United States | 91356 |
| 111 | Pfizer Investigational Site | Torrance | California | United States | 90505 |
| 112 | Pfizer Investigational Site | Tulare | California | United States | 93274 |
| 113 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 114 | Pfizer Investigational Site | Van Nuys | California | United States | 91405 |
| 115 | Pfizer Investigational Site | Victorville | California | United States | 92392 |
| 116 | Pfizer Investigational Site | Victorville | California | United States | 92395 |
| 117 | Pfizer Investigational Site | West Covina | California | United States | 91790 |
| 118 | Pfizer Investigational Site | Westminster | California | United States | 92683 |
| 119 | Pfizer Investigational Site | Whittier | California | United States | 90606 |
| 120 | Pfizer Investigational Site | Wildomar | California | United States | 92595 |
| 121 | Pfizer Investigational Site | Wilmington | California | United States | 90744 |
| 122 | Pfizer Investigational Site | Woodland Hills | California | United States | 91364 |
| 123 | Pfizer Investigational Site | Aurora | Colorado | United States | 80012 |
| 124 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80907 |
| 125 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80920 |
| 126 | Pfizer Investigational Site | Denver | Colorado | United States | 80206 |
| 127 | Pfizer Investigational Site | Denver | Colorado | United States | 80209 |
| 128 | Pfizer Investigational Site | Denver | Colorado | United States | 80219 |
| 129 | Pfizer Investigational Site | Fort Collins | Colorado | United States | 80525 |
| 130 | Pfizer Investigational Site | Golden | Colorado | United States | 80401 |
| 131 | Pfizer Investigational Site | Lakewood | Colorado | United States | 80214 |
| 132 | Pfizer Investigational Site | Lakewood | Colorado | United States | 80226 |
| 133 | Pfizer Investigational Site | Northglenn | Colorado | United States | 80234 |
| 134 | Pfizer Investigational Site | Pueblo | Colorado | United States | 81001 |
| 135 | Pfizer Investigational Site | Avon | Connecticut | United States | 06001 |
| 136 | Pfizer Investigational Site | Brewster | Connecticut | United States | 06010 |
| 137 | Pfizer Investigational Site | Brookfield | Connecticut | United States | 06804 |
| 138 | Pfizer Investigational Site | Cos Cob | Connecticut | United States | 06807 |
| 139 | Pfizer Investigational Site | Hamden | Connecticut | United States | 06518 |
| 140 | Pfizer Investigational Site | Milford | Connecticut | United States | 06460 |
| 141 | Pfizer Investigational Site | Ridgefield | Connecticut | United States | 06877 |
| 142 | Pfizer Investigational Site | Newark | Delaware | United States | 19713 |
| 143 | Pfizer Investigational Site | Smyrna | Delaware | United States | 19977 |
| 144 | Pfizer Investigational Site | Wilmington | Delaware | United States | 19805 |
| 145 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20017 |
| 146 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20020 |
| 147 | Pfizer Investigational Site | Altamonte Springs | Florida | United States | 32701-4810 |
| 148 | Pfizer Investigational Site | Apopka | Florida | United States | 32703 |
| 149 | Pfizer Investigational Site | Beverly Hills | Florida | United States | 34465 |
| 150 | Pfizer Investigational Site | Boynton Beach | Florida | United States | 33437 |
| 151 | Pfizer Investigational Site | Chipley | Florida | United States | 32428 |
| 152 | Pfizer Investigational Site | Clearwater | Florida | United States | 33755 |
| 153 | Pfizer Investigational Site | Clermont | Florida | United States | 34711 |
| 154 | Pfizer Investigational Site | Cocoa Beach | Florida | United States | 32931 |
| 155 | Pfizer Investigational Site | Cocoa | Florida | United States | 32927 |
| 156 | Pfizer Investigational Site | Coral Springs | Florida | United States | 33065 |
| 157 | Pfizer Investigational Site | Crystal River | Florida | United States | 34429 |
| 158 | Pfizer Investigational Site | Cutler Bay | Florida | United States | 33189 |
| 159 | Pfizer Investigational Site | Davie | Florida | United States | 33314 |
| 160 | Pfizer Investigational Site | Daytona Beach | Florida | United States | 32114 |
| 161 | Pfizer Investigational Site | Daytona Beach | Florida | United States | 32117 |
| 162 | Pfizer Investigational Site | DeFuniak Springs | Florida | United States | 32435 |
| 163 | Pfizer Investigational Site | DeLand | Florida | United States | 32720 |
| 164 | Pfizer Investigational Site | Dunnellon | Florida | United States | 34432 |
| 165 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | 33334 |
| 166 | Pfizer Investigational Site | Fort Myers | Florida | United States | 33907 |
| 167 | Pfizer Investigational Site | Gainesville | Florida | United States | 32605 |
| 168 | Pfizer Investigational Site | Green Cove Springs | Florida | United States | 32043 |
| 169 | Pfizer Investigational Site | Hallandale Beach | Florida | United States | 33009 |
| 170 | Pfizer Investigational Site | Hialeah | Florida | United States | 33010 |
| 171 | Pfizer Investigational Site | Hialeah | Florida | United States | 33013 |
| 172 | Pfizer Investigational Site | Hialeah | Florida | United States | 33016 |
| 173 | Pfizer Investigational Site | Hollywood | Florida | United States | 33021 |
| 174 | Pfizer Investigational Site | Hollywood | Florida | United States | 33023 |
| 175 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32257 |
| 176 | Pfizer Investigational Site | Jupiter | Florida | United States | 33458 |
| 177 | Pfizer Investigational Site | Key Biscayne | Florida | United States | 33149 |
| 178 | Pfizer Investigational Site | Kissimmee | Florida | United States | 34741 |
| 179 | Pfizer Investigational Site | Lake Worth | Florida | United States | 33461 |
| 180 | Pfizer Investigational Site | Largo | Florida | United States | 33770 |
| 181 | Pfizer Investigational Site | Melbourne | Florida | United States | 32901 |
| 182 | Pfizer Investigational Site | Melbourne | Florida | United States | 32935 |
| 183 | Pfizer Investigational Site | Miami Beach | Florida | United States | 33139 |
| 184 | Pfizer Investigational Site | Miami | Florida | United States | 33126 |
| 185 | Pfizer Investigational Site | Miami | Florida | United States | 33135 |
| 186 | Pfizer Investigational Site | Miami | Florida | United States | 33144 |
| 187 | Pfizer Investigational Site | Miami | Florida | United States | 33145 |
| 188 | Pfizer Investigational Site | Miami | Florida | United States | 33155 |
| 189 | Pfizer Investigational Site | Miami | Florida | United States | 33157 |
| 190 | Pfizer Investigational Site | Miami | Florida | United States | 33176 |
| 191 | Pfizer Investigational Site | Miami | Florida | United States | 33186 |
| 192 | Pfizer Investigational Site | Niceville | Florida | United States | 32578 |
| 193 | Pfizer Investigational Site | North Miami | Florida | United States | 33161 |
| 194 | Pfizer Investigational Site | Ocala | Florida | United States | 34474 |
| 195 | Pfizer Investigational Site | Orange City | Florida | United States | 32763 |
| 196 | Pfizer Investigational Site | Orlando | Florida | United States | 32804 |
| 197 | Pfizer Investigational Site | Ormond Beach | Florida | United States | 32174 |
| 198 | Pfizer Investigational Site | Oviedo | Florida | United States | 32765 |
| 199 | Pfizer Investigational Site | Palm Bay | Florida | United States | 32907 |
| 200 | Pfizer Investigational Site | Palm Harbor | Florida | United States | 34684 |
| 201 | Pfizer Investigational Site | Panama City | Florida | United States | 32401 |
| 202 | Pfizer Investigational Site | Parkland | Florida | United States | 33067 |
| 203 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33027 |
| 204 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33029 |
| 205 | Pfizer Investigational Site | Pinecrest | Florida | United States | 33156 |
| 206 | Pfizer Investigational Site | Plantation | Florida | United States | 33317 |
| 207 | Pfizer Investigational Site | Plantation | Florida | United States | 33324 |
| 208 | Pfizer Investigational Site | Port Charlotte | Florida | United States | 33952 |
| 209 | Pfizer Investigational Site | Port Orange | Florida | United States | 32129 |
| 210 | Pfizer Investigational Site | Port Richey | Florida | United States | 34668 |
| 211 | Pfizer Investigational Site | Saint Cloud | Florida | United States | 34769 |
| 212 | Pfizer Investigational Site | Saint Petersburg | Florida | United States | 33703 |
| 213 | Pfizer Investigational Site | Saint Petersburg | Florida | United States | 33713 |
| 214 | Pfizer Investigational Site | Sarasota | Florida | United States | 34239 |
| 215 | Pfizer Investigational Site | Sebastian | Florida | United States | 32958-3296 |
| 216 | Pfizer Investigational Site | South Miami | Florida | United States | 33143 |
| 217 | Pfizer Investigational Site | Tallahassee | Florida | United States | 32301 |
| 218 | Pfizer Investigational Site | Tampa | Florida | United States | 33607 |
| 219 | Pfizer Investigational Site | Tampa | Florida | United States | 33613 |
| 220 | Pfizer Investigational Site | Tampa | Florida | United States | 33614 |
| 221 | Pfizer Investigational Site | Tampa | Florida | United States | 33615 |
| 222 | Pfizer Investigational Site | Tampa | Florida | United States | 33619-6364 |
| 223 | Pfizer Investigational Site | Tampa | Florida | United States | 33624 |
| 224 | Pfizer Investigational Site | Vero Beach | Florida | United States | 32960 |
| 225 | Pfizer Investigational Site | Wellington | Florida | United States | 33414 |
| 226 | Pfizer Investigational Site | Athens | Georgia | United States | 30606 |
| 227 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30338 |
| 228 | Pfizer Investigational Site | Bainbridge | Georgia | United States | 39819 |
| 229 | Pfizer Investigational Site | Cairo | Georgia | United States | 39829 |
| 230 | Pfizer Investigational Site | Calhoun | Georgia | United States | 30701 |
| 231 | Pfizer Investigational Site | Cartersville | Georgia | United States | 30120 |
| 232 | Pfizer Investigational Site | Columbus | Georgia | United States | 31904 |
| 233 | Pfizer Investigational Site | Covington | Georgia | United States | 30016 |
| 234 | Pfizer Investigational Site | Cumming | Georgia | United States | 30041 |
| 235 | Pfizer Investigational Site | Dawsonville | Georgia | United States | 30534 |
| 236 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
| 237 | Pfizer Investigational Site | Dunwoody | Georgia | United States | 30338 |
| 238 | Pfizer Investigational Site | Gainesville | Georgia | United States | 30501 |
| 239 | Pfizer Investigational Site | Hampton | Georgia | United States | 30228 |
| 240 | Pfizer Investigational Site | Hinesville | Georgia | United States | 31313 |
| 241 | Pfizer Investigational Site | Lawrenceville | Georgia | United States | 30045 |
| 242 | Pfizer Investigational Site | Macon | Georgia | United States | 31206 |
| 243 | Pfizer Investigational Site | Roswell | Georgia | United States | 30075 |
| 244 | Pfizer Investigational Site | Sandersville | Georgia | United States | 31082 |
| 245 | Pfizer Investigational Site | Savannah | Georgia | United States | 31406 |
| 246 | Pfizer Investigational Site | Snellville | Georgia | United States | 30078 |
| 247 | Pfizer Investigational Site | Stockbridge | Georgia | United States | 30281 |
| 248 | Pfizer Investigational Site | Watkinsville | Georgia | United States | 30677 |
| 249 | Pfizer Investigational Site | Waycross | Georgia | United States | 31501-1943 |
| 250 | Pfizer Investigational Site | 'Aiea | Hawaii | United States | 96701 |
| 251 | Pfizer Investigational Site | Honolulu | Hawaii | United States | 96814 |
| 252 | Pfizer Investigational Site | Honolulu | Hawaii | United States | 96819 |
| 253 | Pfizer Investigational Site | Arlington Heights | Illinois | United States | 60004 |
| 254 | Pfizer Investigational Site | Chicago | Illinois | United States | 60628 |
| 255 | Pfizer Investigational Site | Danville | Illinois | United States | 61832 |
| 256 | Pfizer Investigational Site | DeKalb | Illinois | United States | 60115 |
| 257 | Pfizer Investigational Site | Elgin | Illinois | United States | 60123 |
| 258 | Pfizer Investigational Site | Evergreen Park | Illinois | United States | 60805 |
| 259 | Pfizer Investigational Site | Fairview Heights | Illinois | United States | 62208 |
| 260 | Pfizer Investigational Site | Flossmoor | Illinois | United States | 60422 |
| 261 | Pfizer Investigational Site | Greenville | Illinois | United States | 62246 |
| 262 | Pfizer Investigational Site | Hanna City | Illinois | United States | 61536 |
| 263 | Pfizer Investigational Site | Moline | Illinois | United States | 61265 |
| 264 | Pfizer Investigational Site | Moweaqua | Illinois | United States | 62550 |
| 265 | Pfizer Investigational Site | O'Fallon | Illinois | United States | 62269 |
| 266 | Pfizer Investigational Site | Pekin | Illinois | United States | 61554-6096 |
| 267 | Pfizer Investigational Site | Peoria | Illinois | United States | 61602 |
| 268 | Pfizer Investigational Site | Peoria | Illinois | United States | 61603-4301 |
| 269 | Pfizer Investigational Site | Peoria | Illinois | United States | 61614 |
| 270 | Pfizer Investigational Site | Quincy | Illinois | United States | 62301 |
| 271 | Pfizer Investigational Site | Watseka | Illinois | United States | 60970 |
| 272 | Pfizer Investigational Site | Brownsburg | Indiana | United States | 46112 |
| 273 | Pfizer Investigational Site | Evansville | Indiana | United States | 47710-3807 |
| 274 | Pfizer Investigational Site | Evansville | Indiana | United States | 47712 |
| 275 | Pfizer Investigational Site | Fort Wayne | Indiana | United States | 46809 |
| 276 | Pfizer Investigational Site | Hobart | Indiana | United States | 46342 |
| 277 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46205 |
| 278 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46217 |
| 279 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46250 |
| 280 | Pfizer Investigational Site | LaPorte | Indiana | United States | 46350 |
| 281 | Pfizer Investigational Site | Mishawaka | Indiana | United States | 46545 |
| 282 | Pfizer Investigational Site | New Haven | Indiana | United States | 46774 |
| 283 | Pfizer Investigational Site | South Bend | Indiana | United States | 46601-1071 |
| 284 | Pfizer Investigational Site | South Bend | Indiana | United States | 46601 |
| 285 | Pfizer Investigational Site | Wabash | Indiana | United States | 46992 |
| 286 | Pfizer Investigational Site | Ames | Iowa | United States | 50010 |
| 287 | Pfizer Investigational Site | Cedar Rapids | Iowa | United States | 52401 |
| 288 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50315 |
| 289 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50316 |
| 290 | Pfizer Investigational Site | Dubuque | Iowa | United States | 52002 |
| 291 | Pfizer Investigational Site | Fort Dodge | Iowa | United States | 50501 |
| 292 | Pfizer Investigational Site | Waterloo | Iowa | United States | 50701 |
| 293 | Pfizer Investigational Site | West Burlington | Iowa | United States | 52655 |
| 294 | Pfizer Investigational Site | Arkansas City | Kansas | United States | 67005 |
| 295 | Pfizer Investigational Site | Kansas City | Kansas | United States | 66101 |
| 296 | Pfizer Investigational Site | Kansas City | Kansas | United States | 66109 |
| 297 | Pfizer Investigational Site | Mission | Kansas | United States | 66202-2722 |
| 298 | Pfizer Investigational Site | Newton | Kansas | United States | 67114 |
| 299 | Pfizer Investigational Site | Pratt | Kansas | United States | 67124 |
| 300 | Pfizer Investigational Site | Shawnee Mission | Kansas | United States | 66203 |
| 301 | Pfizer Investigational Site | Topeka | Kansas | United States | 66614 |
| 302 | Pfizer Investigational Site | Wellington | Kansas | United States | 67152 |
| 303 | Pfizer Investigational Site | Wichita | Kansas | United States | 67205 |
| 304 | Pfizer Investigational Site | Wichita | Kansas | United States | 67207 |
| 305 | Pfizer Investigational Site | Bowling Green | Kentucky | United States | 42104 |
| 306 | Pfizer Investigational Site | Draffenville | Kentucky | United States | 42025 |
| 307 | Pfizer Investigational Site | Hartford | Kentucky | United States | 42347 |
| 308 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40504 |
| 309 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40258 |
| 310 | Pfizer Investigational Site | Mount Sterling | Kentucky | United States | 40353 |
| 311 | Pfizer Investigational Site | Paducah | Kentucky | United States | 42003 |
| 312 | Pfizer Investigational Site | Richmond | Kentucky | United States | 40475 |
| 313 | Pfizer Investigational Site | Alexandria | Louisiana | United States | 71301 |
| 314 | Pfizer Investigational Site | Baton Rouge | Louisiana | United States | 70806 |
| 315 | Pfizer Investigational Site | Jena | Louisiana | United States | 71342 |
| 316 | Pfizer Investigational Site | Jonesboro | Louisiana | United States | 71251 |
| 317 | Pfizer Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 318 | Pfizer Investigational Site | Metairie | Louisiana | United States | 70006 |
| 319 | Pfizer Investigational Site | Monroe | Louisiana | United States | 71201 |
| 320 | Pfizer Investigational Site | Monroe | Louisiana | United States | 71203 |
| 321 | Pfizer Investigational Site | Natchitoches | Louisiana | United States | 71457 |
| 322 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70115 |
| 323 | Pfizer Investigational Site | Shreveport | Louisiana | United States | 71105 |
| 324 | Pfizer Investigational Site | Shreveport | Louisiana | United States | 71106 |
| 325 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21209 |
| 326 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21218 |
| 327 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21234-4607 |
| 328 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21286 |
| 329 | Pfizer Investigational Site | Bel Air | Maryland | United States | 21015 |
| 330 | Pfizer Investigational Site | Bladensburg | Maryland | United States | 20710 |
| 331 | Pfizer Investigational Site | College Park | Maryland | United States | 20740 |
| 332 | Pfizer Investigational Site | Elkton | Maryland | United States | 21921-5230 |
| 333 | Pfizer Investigational Site | Ellicott City | Maryland | United States | 21042 |
| 334 | Pfizer Investigational Site | Frederick | Maryland | United States | 21702 |
| 335 | Pfizer Investigational Site | Mount Airy | Maryland | United States | 21771 |
| 336 | Pfizer Investigational Site | Prince Frederick | Maryland | United States | 20678 |
| 337 | Pfizer Investigational Site | Riverdale | Maryland | United States | 20737 |
| 338 | Pfizer Investigational Site | Rockville | Maryland | United States | 20852 |
| 339 | Pfizer Investigational Site | Rockville | Maryland | United States | 20854-2957 |
| 340 | Pfizer Investigational Site | Silver Spring | Maryland | United States | 20901 |
| 341 | Pfizer Investigational Site | Towson | Maryland | United States | 21286 |
| 342 | Pfizer Investigational Site | Wheaton | Maryland | United States | 20902 |
| 343 | Pfizer Investigational Site | Attleboro | Massachusetts | United States | 02762 |
| 344 | Pfizer Investigational Site | Fall River | Massachusetts | United States | 02720 |
| 345 | Pfizer Investigational Site | North Andover | Massachusetts | United States | 01875 |
| 346 | Pfizer Investigational Site | North Dartmouth | Massachusetts | United States | 02747 |
| 347 | Pfizer Investigational Site | Taunton | Massachusetts | United States | 02780 |
| 348 | Pfizer Investigational Site | Berkley | Michigan | United States | 48072 |
| 349 | Pfizer Investigational Site | Brighton | Michigan | United States | 48116 |
| 350 | Pfizer Investigational Site | Cadillac | Michigan | United States | 49601 |
| 351 | Pfizer Investigational Site | Chelsea | Michigan | United States | 48118 |
| 352 | Pfizer Investigational Site | Clarkston | Michigan | United States | 48346 |
| 353 | Pfizer Investigational Site | Detroit | Michigan | United States | 48221 |
| 354 | Pfizer Investigational Site | Fair Haven | Michigan | United States | 48023 |
| 355 | Pfizer Investigational Site | Fenton | Michigan | United States | 48430 |
| 356 | Pfizer Investigational Site | Flint | Michigan | United States | 48507 |
| 357 | Pfizer Investigational Site | Grand Ledge | Michigan | United States | 48837 |
| 358 | Pfizer Investigational Site | Grand Rapids | Michigan | United States | 49546 |
| 359 | Pfizer Investigational Site | Interlochen | Michigan | United States | 49643 |
| 360 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49009 |
| 361 | Pfizer Investigational Site | Lansing | Michigan | United States | 48910 |
| 362 | Pfizer Investigational Site | Lansing | Michigan | United States | 48917 |
| 363 | Pfizer Investigational Site | Livonia | Michigan | United States | 48150 |
| 364 | Pfizer Investigational Site | Parchment | Michigan | United States | 49004 |
| 365 | Pfizer Investigational Site | Pigeon | Michigan | United States | 48755 |
| 366 | Pfizer Investigational Site | Saginaw | Michigan | United States | 48602 |
| 367 | Pfizer Investigational Site | Saint Clair Shores | Michigan | United States | 48081 |
| 368 | Pfizer Investigational Site | Saint Joseph | Michigan | United States | 49085-8511 |
| 369 | Pfizer Investigational Site | Southfield | Michigan | United States | 48034 |
| 370 | Pfizer Investigational Site | Southfield | Michigan | United States | 48075 |
| 371 | Pfizer Investigational Site | Southgate | Michigan | United States | 48195 |
| 372 | Pfizer Investigational Site | Sterling Heights | Michigan | United States | 48310 |
| 373 | Pfizer Investigational Site | Sturgis | Michigan | United States | 49091 |
| 374 | Pfizer Investigational Site | Traverse City | Michigan | United States | 49684 |
| 375 | Pfizer Investigational Site | Troy | Michigan | United States | 48084 |
| 376 | Pfizer Investigational Site | Troy | Michigan | United States | 48085 |
| 377 | Pfizer Investigational Site | West Branch | Michigan | United States | 48661 |
| 378 | Pfizer Investigational Site | Ypsilanti | Michigan | United States | 48197 |
| 379 | Pfizer Investigational Site | Belzoni | Mississippi | United States | 39038 |
| 380 | Pfizer Investigational Site | Hattiesburg | Mississippi | United States | 39402 |
| 381 | Pfizer Investigational Site | Jackson | Mississippi | United States | 39202 |
| 382 | Pfizer Investigational Site | Jackson | Mississippi | United States | 39209 |
| 383 | Pfizer Investigational Site | Jackson | Mississippi | United States | 39211 |
| 384 | Pfizer Investigational Site | Magee | Mississippi | United States | 39111 |
| 385 | Pfizer Investigational Site | Picayune | Mississippi | United States | 39466 |
| 386 | Pfizer Investigational Site | Port Gibson | Mississippi | United States | 39150 |
| 387 | Pfizer Investigational Site | Prentiss | Mississippi | United States | 39474 |
| 388 | Pfizer Investigational Site | Sumrall | Mississippi | United States | 39482 |
| 389 | Pfizer Investigational Site | Florissant | Missouri | United States | 63033 |
| 390 | Pfizer Investigational Site | Jackson | Missouri | United States | 63755 |
| 391 | Pfizer Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 392 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64114 |
| 393 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64158 |
| 394 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63139 |
| 395 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 396 | Pfizer Investigational Site | Saint Peters | Missouri | United States | 63376 |
| 397 | Pfizer Investigational Site | Springfield | Missouri | United States | 65804 |
| 398 | Pfizer Investigational Site | Missoula | Montana | United States | 59804 |
| 399 | Pfizer Investigational Site | Alliance | Nebraska | United States | 69301 |
| 400 | Pfizer Investigational Site | Beatrice | Nebraska | United States | 68310 |
| 401 | Pfizer Investigational Site | Broken Bow | Nebraska | United States | 68822 |
| 402 | Pfizer Investigational Site | Fremont | Nebraska | United States | 68025 |
| 403 | Pfizer Investigational Site | Grand Island | Nebraska | United States | 68803 |
| 404 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68516 |
| 405 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68526 |
| 406 | Pfizer Investigational Site | McCook | Nebraska | United States | 69001 |
| 407 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68116-2004 |
| 408 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68124 |
| 409 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68134 |
| 410 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68144 |
| 411 | Pfizer Investigational Site | Incline Village | Nevada | United States | 89452 |
| 412 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89101 |
| 413 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89128 |
| 414 | Pfizer Investigational Site | Belvidere | New Jersey | United States | 07823 |
| 415 | Pfizer Investigational Site | Berlin | New Jersey | United States | 08009 |
| 416 | Pfizer Investigational Site | Blackwood | New Jersey | United States | 08012 |
| 417 | Pfizer Investigational Site | Bridgeport | New Jersey | United States | 08014 |
| 418 | Pfizer Investigational Site | Bridgeton | New Jersey | United States | 08302 |
| 419 | Pfizer Investigational Site | Clementon | New Jersey | United States | 08021 |
| 420 | Pfizer Investigational Site | Egg Harbor Township | New Jersey | United States | 08234 |
| 421 | Pfizer Investigational Site | Elizabeth | New Jersey | United States | 07201 |
| 422 | Pfizer Investigational Site | Elizabeth | New Jersey | United States | 07202 |
| 423 | Pfizer Investigational Site | Flanders | New Jersey | United States | 07836 |
| 424 | Pfizer Investigational Site | Freehold | New Jersey | United States | 07728 |
| 425 | Pfizer Investigational Site | Glendora | New Jersey | United States | 08029 |
| 426 | Pfizer Investigational Site | Holmdel | New Jersey | United States | 07733 |
| 427 | Pfizer Investigational Site | Lincoln Park | New Jersey | United States | 07035 |
| 428 | Pfizer Investigational Site | Linden | New Jersey | United States | 07036 |
| 429 | Pfizer Investigational Site | Midland Park | New Jersey | United States | 07432 |
| 430 | Pfizer Investigational Site | North Arlington | New Jersey | United States | 07031 |
| 431 | Pfizer Investigational Site | Passaic | New Jersey | United States | 07055 |
| 432 | Pfizer Investigational Site | South Bound Brook | New Jersey | United States | 08880 |
| 433 | Pfizer Investigational Site | Voorhees | New Jersey | United States | 08043 |
| 434 | Pfizer Investigational Site | Whitehouse Station | New Jersey | United States | 08889 |
| 435 | Pfizer Investigational Site | Wildwood Crest | New Jersey | United States | 08260 |
| 436 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 437 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87111 |
| 438 | Pfizer Investigational Site | Los Alamos | New Mexico | United States | 87544 |
| 439 | Pfizer Investigational Site | Albany | New York | United States | 12206 |
| 440 | Pfizer Investigational Site | Brooklyn | New York | United States | 11203-2711 |
| 441 | Pfizer Investigational Site | Brooklyn | New York | United States | 11224 |
| 442 | Pfizer Investigational Site | East Syracuse | New York | United States | 13057 |
| 443 | Pfizer Investigational Site | Elmhurst | New York | United States | 11373 |
| 444 | Pfizer Investigational Site | Far Rockaway | New York | United States | 11691 |
| 445 | Pfizer Investigational Site | Fayetteville | New York | United States | 13066 |
| 446 | Pfizer Investigational Site | Flushing | New York | United States | 11355-2642 |
| 447 | Pfizer Investigational Site | Flushing | New York | United States | 11358 |
| 448 | Pfizer Investigational Site | Forest Hills | New York | United States | 11375 |
| 449 | Pfizer Investigational Site | Lake Success | New York | United States | 11042 |
| 450 | Pfizer Investigational Site | Lewiston | New York | United States | 14092 |
| 451 | Pfizer Investigational Site | Liverpool | New York | United States | 13088 |
| 452 | Pfizer Investigational Site | New Hartford | New York | United States | 13413 |
| 453 | Pfizer Investigational Site | New Windsor | New York | United States | 12553 |
| 454 | Pfizer Investigational Site | New York | New York | United States | 10004 |
| 455 | Pfizer Investigational Site | New York | New York | United States | 10025 |
| 456 | Pfizer Investigational Site | Olean | New York | United States | 14760 |
| 457 | Pfizer Investigational Site | Orchard Park | New York | United States | 14127 |
| 458 | Pfizer Investigational Site | Plainview | New York | United States | 11803 |
| 459 | Pfizer Investigational Site | Rye Brook | New York | United States | 10573 |
| 460 | Pfizer Investigational Site | Salamanca | New York | United States | 14779 |
| 461 | Pfizer Investigational Site | Syracuse | New York | United States | 13208 |
| 462 | Pfizer Investigational Site | Tonawanda | New York | United States | 14150 |
| 463 | Pfizer Investigational Site | Wantagh | New York | United States | 11793 |
| 464 | Pfizer Investigational Site | Warsaw | New York | United States | 14569 |
| 465 | Pfizer Investigational Site | West Babylon | New York | United States | 11702 |
| 466 | Pfizer Investigational Site | Williamsville | New York | United States | 14221 |
| 467 | Pfizer Investigational Site | Asheboro | North Carolina | United States | 27203 |
| 468 | Pfizer Investigational Site | Boone | North Carolina | United States | 28607 |
| 469 | Pfizer Investigational Site | Bunn | North Carolina | United States | 27508 |
| 470 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28210 |
| 471 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28262 |
| 472 | Pfizer Investigational Site | Durham | North Carolina | United States | 27704 |
| 473 | Pfizer Investigational Site | Elizabeth City | North Carolina | United States | 27909 |
| 474 | Pfizer Investigational Site | Gastonia | North Carolina | United States | 28056 |
| 475 | Pfizer Investigational Site | Greensboro | North Carolina | United States | 27401 |
| 476 | Pfizer Investigational Site | Greenville | North Carolina | United States | 27834 |
| 477 | Pfizer Investigational Site | Huntersville | North Carolina | United States | 28078 |
| 478 | Pfizer Investigational Site | Jacksonville | North Carolina | United States | 28546 |
| 479 | Pfizer Investigational Site | Kinston | North Carolina | United States | 28501 |
| 480 | Pfizer Investigational Site | Lenoir | North Carolina | United States | 28645 |
| 481 | Pfizer Investigational Site | Monroe | North Carolina | United States | 28112 |
| 482 | Pfizer Investigational Site | New Bern | North Carolina | United States | 28562 |
| 483 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27607-6475 |
| 484 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 485 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27610 |
| 486 | Pfizer Investigational Site | Shelby | North Carolina | United States | 28150 |
| 487 | Pfizer Investigational Site | Statesville | North Carolina | United States | 28625 |
| 488 | Pfizer Investigational Site | Tabor City | North Carolina | United States | 28463 |
| 489 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 490 | Pfizer Investigational Site | Akron | Ohio | United States | 44310-1453 |
| 491 | Pfizer Investigational Site | Boardman | Ohio | United States | 44512 |
| 492 | Pfizer Investigational Site | Canton | Ohio | United States | 44708 |
| 493 | Pfizer Investigational Site | Carlisle | Ohio | United States | 45005 |
| 494 | Pfizer Investigational Site | Centerville | Ohio | United States | 45459 |
| 495 | Pfizer Investigational Site | Chardon | Ohio | United States | 44024 |
| 496 | Pfizer Investigational Site | Chesterland | Ohio | United States | 44026 |
| 497 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45224 |
| 498 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45236 |
| 499 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45242 |
| 500 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44103 |
| 501 | Pfizer Investigational Site | Columbus | Ohio | United States | 43207 |
| 502 | Pfizer Investigational Site | Columbus | Ohio | United States | 43212 |
| 503 | Pfizer Investigational Site | Columbus | Ohio | United States | 43213 |
| 504 | Pfizer Investigational Site | Columbus | Ohio | United States | 43215 |
| 505 | Pfizer Investigational Site | Columbus | Ohio | United States | 43230-8703 |
| 506 | Pfizer Investigational Site | Cortland | Ohio | United States | 44410 |
| 507 | Pfizer Investigational Site | Dayton | Ohio | United States | 45458 |
| 508 | Pfizer Investigational Site | Delaware | Ohio | United States | 43015 |
| 509 | Pfizer Investigational Site | Fairborn | Ohio | United States | 45324 |
| 510 | Pfizer Investigational Site | Franklin | Ohio | United States | 45005 |
| 511 | Pfizer Investigational Site | Genoa | Ohio | United States | 43430 |
| 512 | Pfizer Investigational Site | Lyndhurst | Ohio | United States | 44124 |
| 513 | Pfizer Investigational Site | Marietta | Ohio | United States | 45750 |
| 514 | Pfizer Investigational Site | Marion | Ohio | United States | 43302 |
| 515 | Pfizer Investigational Site | Mason | Ohio | United States | 45640 |
| 516 | Pfizer Investigational Site | McConnelsville | Ohio | United States | 43756 |
| 517 | Pfizer Investigational Site | Middleburg Heights | Ohio | United States | 44130 |
| 518 | Pfizer Investigational Site | Middletown | Ohio | United States | 45044 |
| 519 | Pfizer Investigational Site | New Lexington | Ohio | United States | 43764 |
| 520 | Pfizer Investigational Site | Orrville | Ohio | United States | 44667 |
| 521 | Pfizer Investigational Site | Shaker Heights | Ohio | United States | 44120 |
| 522 | Pfizer Investigational Site | Toledo | Ohio | United States | 43606 |
| 523 | Pfizer Investigational Site | Toledo | Ohio | United States | 43615 |
| 524 | Pfizer Investigational Site | Trenton | Ohio | United States | 45067 |
| 525 | Pfizer Investigational Site | Wadsworth | Ohio | United States | 44281 |
| 526 | Pfizer Investigational Site | Warren | Ohio | United States | 44485 |
| 527 | Pfizer Investigational Site | Westlake | Ohio | United States | 44145 |
| 528 | Pfizer Investigational Site | Willoughby Hills | Ohio | United States | 44094 |
| 529 | Pfizer Investigational Site | Wooster | Ohio | United States | 44691 |
| 530 | Pfizer Investigational Site | Zanesville | Ohio | United States | 43701 |
| 531 | Pfizer Investigational Site | Bethany | Oklahoma | United States | 73008 |
| 532 | Pfizer Investigational Site | Edmond | Oklahoma | United States | 73034 |
| 533 | Pfizer Investigational Site | Moore | Oklahoma | United States | 73160 |
| 534 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73134 |
| 535 | Pfizer Investigational Site | Stillwater | Oklahoma | United States | 74074 |
| 536 | Pfizer Investigational Site | Tulsa | Oklahoma | United States | 74114 |
| 537 | Pfizer Investigational Site | Yukon | Oklahoma | United States | 73099 |
| 538 | Pfizer Investigational Site | Grants Pass | Oregon | United States | 97526 |
| 539 | Pfizer Investigational Site | Hermiston | Oregon | United States | 97838 |
| 540 | Pfizer Investigational Site | Medford | Oregon | United States | 97504 |
| 541 | Pfizer Investigational Site | Portland | Oregon | United States | 97219 |
| 542 | Pfizer Investigational Site | Portland | Oregon | United States | 97227 |
| 543 | Pfizer Investigational Site | Aston | Pennsylvania | United States | 19014 |
| 544 | Pfizer Investigational Site | Audubon | Pennsylvania | United States | 19403 |
| 545 | Pfizer Investigational Site | Bensalem | Pennsylvania | United States | 19020 |
| 546 | Pfizer Investigational Site | Bethlehem | Pennsylvania | United States | 18015 |
| 547 | Pfizer Investigational Site | Bristol | Pennsylvania | United States | 19007 |
| 548 | Pfizer Investigational Site | Broomall | Pennsylvania | United States | 19008 |
| 549 | Pfizer Investigational Site | Butler | Pennsylvania | United States | 16001 |
| 550 | Pfizer Investigational Site | Camp Hill | Pennsylvania | United States | 17011 |
| 551 | Pfizer Investigational Site | Carnegie | Pennsylvania | United States | 15106 |
| 552 | Pfizer Investigational Site | Chester | Pennsylvania | United States | 19013 |
| 553 | Pfizer Investigational Site | Chicora | Pennsylvania | United States | 16025 |
| 554 | Pfizer Investigational Site | Cresson | Pennsylvania | United States | 16630 |
| 555 | Pfizer Investigational Site | Dallastown | Pennsylvania | United States | 17313 |
| 556 | Pfizer Investigational Site | Dauphin | Pennsylvania | United States | 17018 |
| 557 | Pfizer Investigational Site | Downingtown | Pennsylvania | United States | 19335 |
| 558 | Pfizer Investigational Site | Duncansville | Pennsylvania | United States | 16635 |
| 559 | Pfizer Investigational Site | Erie | Pennsylvania | United States | 16504 |
| 560 | Pfizer Investigational Site | Erie | Pennsylvania | United States | 16508-1256 |
| 561 | Pfizer Investigational Site | Fleetwood | Pennsylvania | United States | 19522 |
| 562 | Pfizer Investigational Site | Flourtown | Pennsylvania | United States | 19301 |
| 563 | Pfizer Investigational Site | Fogelsville | Pennsylvania | United States | 18051 |
| 564 | Pfizer Investigational Site | Greensburg | Pennsylvania | United States | 15601 |
| 565 | Pfizer Investigational Site | Harrisburg | Pennsylvania | United States | 17111 |
| 566 | Pfizer Investigational Site | Harrisburg | Pennsylvania | United States | 17112 |
| 567 | Pfizer Investigational Site | Hatboro | Pennsylvania | United States | 19040 |
| 568 | Pfizer Investigational Site | Hatfield | Pennsylvania | United States | 19440 |
| 569 | Pfizer Investigational Site | Jeannette | Pennsylvania | United States | 15644 |
| 570 | Pfizer Investigational Site | Jefferson Hills | Pennsylvania | United States | 15025 |
| 571 | Pfizer Investigational Site | Johnstown | Pennsylvania | United States | 15901 |
| 572 | Pfizer Investigational Site | King Of Prussia | Pennsylvania | United States | 19406 |
| 573 | Pfizer Investigational Site | Lancaster | Pennsylvania | United States | 17601 |
| 574 | Pfizer Investigational Site | Lansdale | Pennsylvania | United States | 19446-1004 |
| 575 | Pfizer Investigational Site | Lansdale | Pennsylvania | United States | 19446 |
| 576 | Pfizer Investigational Site | Millvale | Pennsylvania | United States | 15209 |
| 577 | Pfizer Investigational Site | Morrisville | Pennsylvania | United States | 19067 |
| 578 | Pfizer Investigational Site | Northern Cambria | Pennsylvania | United States | 15714 |
| 579 | Pfizer Investigational Site | Penndel | Pennsylvania | United States | 19047 |
| 580 | Pfizer Investigational Site | Pennsburg | Pennsylvania | United States | 18073 |
| 581 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19124 |
| 582 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19138 |
| 583 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19148-2115 |
| 584 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19152 |
| 585 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19153-2326 |
| 586 | Pfizer Investigational Site | Phoenixville | Pennsylvania | United States | 19460 |
| 587 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15243 |
| 588 | Pfizer Investigational Site | Port Carbon | Pennsylvania | United States | 17965 |
| 589 | Pfizer Investigational Site | Pottstown | Pennsylvania | United States | 19464 |
| 590 | Pfizer Investigational Site | Reading | Pennsylvania | United States | 19606 |
| 591 | Pfizer Investigational Site | Scranton | Pennsylvania | United States | 18510 |
| 592 | Pfizer Investigational Site | Thorndale | Pennsylvania | United States | 19372 |
| 593 | Pfizer Investigational Site | Tipton | Pennsylvania | United States | 16684 |
| 594 | Pfizer Investigational Site | Uniontown | Pennsylvania | United States | 15401 |
| 595 | Pfizer Investigational Site | Upper Saint Clair | Pennsylvania | United States | 15241 |
| 596 | Pfizer Investigational Site | Wexford | Pennsylvania | United States | 15090-8405 |
| 597 | Pfizer Investigational Site | Zionsville | Pennsylvania | United States | 18092 |
| 598 | Pfizer Investigational Site | Cranston | Rhode Island | United States | 02920 |
| 599 | Pfizer Investigational Site | East Providence | Rhode Island | United States | 02914 |
| 600 | Pfizer Investigational Site | Providence | Rhode Island | United States | 02906 |
| 601 | Pfizer Investigational Site | Warwick | Rhode Island | United States | 02888 |
| 602 | Pfizer Investigational Site | Anderson | South Carolina | United States | 29621 |
| 603 | Pfizer Investigational Site | Bluffton | South Carolina | United States | 29910 |
| 604 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29414 |
| 605 | Pfizer Investigational Site | Clemson | South Carolina | United States | 29631 |
| 606 | Pfizer Investigational Site | Clinton | South Carolina | United States | 29325 |
| 607 | Pfizer Investigational Site | Columbia | South Carolina | United States | 29204 |
| 608 | Pfizer Investigational Site | Gaffney | South Carolina | United States | 29340 |
| 609 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29601-3973 |
| 610 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29601 |
| 611 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29605 |
| 612 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29615 |
| 613 | Pfizer Investigational Site | Greer | South Carolina | United States | 29651 |
| 614 | Pfizer Investigational Site | Landrum | South Carolina | United States | 29356 |
| 615 | Pfizer Investigational Site | Marion | South Carolina | United States | 29571 |
| 616 | Pfizer Investigational Site | Myrtle Beach | South Carolina | United States | 29572 |
| 617 | Pfizer Investigational Site | Newberry | South Carolina | United States | 29108 |
| 618 | Pfizer Investigational Site | North Myrtle Beach | South Carolina | United States | 29582 |
| 619 | Pfizer Investigational Site | Orangeburg | South Carolina | United States | 29115 |
| 620 | Pfizer Investigational Site | Orangeburg | South Carolina | United States | 29118 |
| 621 | Pfizer Investigational Site | Peak | South Carolina | United States | 29122 |
| 622 | Pfizer Investigational Site | Simpsonville | South Carolina | United States | 29681 |
| 623 | Pfizer Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 624 | Pfizer Investigational Site | Taylors | South Carolina | United States | 29687 |
| 625 | Pfizer Investigational Site | Union | South Carolina | United States | 29379 |
| 626 | Pfizer Investigational Site | Bolivar | Tennessee | United States | 38008 |
| 627 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | 37421 |
| 628 | Pfizer Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 629 | Pfizer Investigational Site | Collierville | Tennessee | United States | 38017 |
| 630 | Pfizer Investigational Site | Germantown | Tennessee | United States | 38138 |
| 631 | Pfizer Investigational Site | Hendersonville | Tennessee | United States | 37075 |
| 632 | Pfizer Investigational Site | Humboldt | Tennessee | United States | 38343 |
| 633 | Pfizer Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 634 | Pfizer Investigational Site | Maynardville | Tennessee | United States | 37807 |
| 635 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38125 |
| 636 | Pfizer Investigational Site | Morristown | Tennessee | United States | 37813 |
| 637 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 638 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37205 |
| 639 | Pfizer Investigational Site | New Tazewell | Tennessee | United States | 37825 |
| 640 | Pfizer Investigational Site | Springfield | Tennessee | United States | 37172 |
| 641 | Pfizer Investigational Site | Amarillo | Texas | United States | 79106 |
| 642 | Pfizer Investigational Site | Arlington | Texas | United States | 76017 |
| 643 | Pfizer Investigational Site | Austin | Texas | United States | 78705 |
| 644 | Pfizer Investigational Site | Austin | Texas | United States | 78750 |
| 645 | Pfizer Investigational Site | Azle | Texas | United States | 76020 |
| 646 | Pfizer Investigational Site | Carrollton | Texas | United States | 75007 |
| 647 | Pfizer Investigational Site | Carrollton | Texas | United States | 75010 |
| 648 | Pfizer Investigational Site | Colleyville | Texas | United States | 76034 |
| 649 | Pfizer Investigational Site | Corpus Christi | Texas | United States | 78404 |
| 650 | Pfizer Investigational Site | Dallas | Texas | United States | 75208 |
| 651 | Pfizer Investigational Site | Dallas | Texas | United States | 75220 |
| 652 | Pfizer Investigational Site | Dallas | Texas | United States | 75224 |
| 653 | Pfizer Investigational Site | Dallas | Texas | United States | 75231 |
| 654 | Pfizer Investigational Site | DeSoto | Texas | United States | 75115 |
| 655 | Pfizer Investigational Site | Farmers Branch | Texas | United States | 75234 |
| 656 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76104 |
| 657 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76106 |
| 658 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76109 |
| 659 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76116 |
| 660 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76137 |
| 661 | Pfizer Investigational Site | Frisco | Texas | United States | 75034 |
| 662 | Pfizer Investigational Site | Garland | Texas | United States | 75043 |
| 663 | Pfizer Investigational Site | Grand Prairie | Texas | United States | 75050 |
| 664 | Pfizer Investigational Site | Grand Prairie | Texas | United States | 75052 |
| 665 | Pfizer Investigational Site | Grapevine | Texas | United States | 76051 |
| 666 | Pfizer Investigational Site | Henderson | Texas | United States | 75652 |
| 667 | Pfizer Investigational Site | Houston | Texas | United States | 77004 |
| 668 | Pfizer Investigational Site | Houston | Texas | United States | 77008 |
| 669 | Pfizer Investigational Site | Houston | Texas | United States | 77024 |
| 670 | Pfizer Investigational Site | Houston | Texas | United States | 77034 |
| 671 | Pfizer Investigational Site | Houston | Texas | United States | 77055 |
| 672 | Pfizer Investigational Site | Houston | Texas | United States | 77057 |
| 673 | Pfizer Investigational Site | Houston | Texas | United States | 77070 |
| 674 | Pfizer Investigational Site | Houston | Texas | United States | 77074 |
| 675 | Pfizer Investigational Site | Houston | Texas | United States | 77082 |
| 676 | Pfizer Investigational Site | Houston | Texas | United States | 77088 |
| 677 | Pfizer Investigational Site | Houston | Texas | United States | 77089 |
| 678 | Pfizer Investigational Site | Houston | Texas | United States | 77090 |
| 679 | Pfizer Investigational Site | Humble | Texas | United States | 77338 |
| 680 | Pfizer Investigational Site | Hurst | Texas | United States | 76054 |
| 681 | Pfizer Investigational Site | Irving | Texas | United States | 75039 |
| 682 | Pfizer Investigational Site | Irving | Texas | United States | 75061 |
| 683 | Pfizer Investigational Site | Katy | Texas | United States | 77450 |
| 684 | Pfizer Investigational Site | Killeen | Texas | United States | 76543 |
| 685 | Pfizer Investigational Site | McKinney | Texas | United States | 75069 |
| 686 | Pfizer Investigational Site | McKinney | Texas | United States | 75071 |
| 687 | Pfizer Investigational Site | Midland | Texas | United States | 79705 |
| 688 | Pfizer Investigational Site | Missouri City | Texas | United States | 77459 |
| 689 | Pfizer Investigational Site | Nederland | Texas | United States | 77627 |
| 690 | Pfizer Investigational Site | New Braunfels | Texas | United States | 78130 |
| 691 | Pfizer Investigational Site | North Richland Hills | Texas | United States | 76180 |
| 692 | Pfizer Investigational Site | Odessa | Texas | United States | 79761 |
| 693 | Pfizer Investigational Site | Plano | Texas | United States | 75024 |
| 694 | Pfizer Investigational Site | Plano | Texas | United States | 75075 |
| 695 | Pfizer Investigational Site | Plano | Texas | United States | 75093 |
| 696 | Pfizer Investigational Site | Pleasanton | Texas | United States | 78064 |
| 697 | Pfizer Investigational Site | Poteet | Texas | United States | 78065 |
| 698 | Pfizer Investigational Site | Richardson | Texas | United States | 75080 |
| 699 | Pfizer Investigational Site | Richmond | Texas | United States | 77469 |
| 700 | Pfizer Investigational Site | Rockwall | Texas | United States | 75032 |
| 701 | Pfizer Investigational Site | San Antonio | Texas | United States | 78205 |
| 702 | Pfizer Investigational Site | San Antonio | Texas | United States | 78212 |
| 703 | Pfizer Investigational Site | San Antonio | Texas | United States | 78224 |
| 704 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 705 | Pfizer Investigational Site | San Antonio | Texas | United States | 78230 |
| 706 | Pfizer Investigational Site | San Antonio | Texas | United States | 78258 |
| 707 | Pfizer Investigational Site | San Marcos | Texas | United States | 78666 |
| 708 | Pfizer Investigational Site | Seguin | Texas | United States | 78155 |
| 709 | Pfizer Investigational Site | Southlake | Texas | United States | 76092 |
| 710 | Pfizer Investigational Site | Spring | Texas | United States | 77386 |
| 711 | Pfizer Investigational Site | Stephenville | Texas | United States | 76401 |
| 712 | Pfizer Investigational Site | Sugar Land | Texas | United States | 77478 |
| 713 | Pfizer Investigational Site | Sugar Land | Texas | United States | 77479 |
| 714 | Pfizer Investigational Site | Sulphur Springs | Texas | United States | 75482 |
| 715 | Pfizer Investigational Site | The Woodlands | Texas | United States | 77381-3528 |
| 716 | Pfizer Investigational Site | Tomball | Texas | United States | 77375-4551 |
| 717 | Pfizer Investigational Site | Tomball | Texas | United States | 77375 |
| 718 | Pfizer Investigational Site | Waco | Texas | United States | 76708 |
| 719 | Pfizer Investigational Site | Webster | Texas | United States | 77598 |
| 720 | Pfizer Investigational Site | Wichita Falls | Texas | United States | 76309 |
| 721 | Pfizer Investigational Site | Bountiful | Utah | United States | 84010 |
| 722 | Pfizer Investigational Site | Clinton | Utah | United States | 84015-8324 |
| 723 | Pfizer Investigational Site | Layton | Utah | United States | 84041 |
| 724 | Pfizer Investigational Site | Saint George | Utah | United States | 84790 |
| 725 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84102 |
| 726 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84124 |
| 727 | Pfizer Investigational Site | West Jordan | Utah | United States | 84088 |
| 728 | Pfizer Investigational Site | Annandale | Virginia | United States | 22003 |
| 729 | Pfizer Investigational Site | Bluefield | Virginia | United States | 24605 |
| 730 | Pfizer Investigational Site | Chatham | Virginia | United States | 24531 |
| 731 | Pfizer Investigational Site | Chesapeake | Virginia | United States | 23320 |
| 732 | Pfizer Investigational Site | Danville | Virginia | United States | 24541 |
| 733 | Pfizer Investigational Site | Hampton | Virginia | United States | 23666 |
| 734 | Pfizer Investigational Site | Honaker | Virginia | United States | 24260 |
| 735 | Pfizer Investigational Site | Leesburg | Virginia | United States | 20175 |
| 736 | Pfizer Investigational Site | Norfolk | Virginia | United States | 23502 |
| 737 | Pfizer Investigational Site | Portsmouth | Virginia | United States | 23701 |
| 738 | Pfizer Investigational Site | Richmond | Virginia | United States | 23219 |
| 739 | Pfizer Investigational Site | Vienna | Virginia | United States | 22182 |
| 740 | Pfizer Investigational Site | Virginia Beach | Virginia | United States | 23452 |
| 741 | Pfizer Investigational Site | Bellevue | Washington | United States | 98004 |
| 742 | Pfizer Investigational Site | Pasco | Washington | United States | 99301 |
| 743 | Pfizer Investigational Site | Selah | Washington | United States | 98942 |
| 744 | Pfizer Investigational Site | Spokane | Washington | United States | 99204 |
| 745 | Pfizer Investigational Site | Spokane | Washington | United States | 99216 |
| 746 | Pfizer Investigational Site | Tacoma | Washington | United States | 98405 |
| 747 | Pfizer Investigational Site | Walla Walla | Washington | United States | 99362 |
| 748 | Pfizer Investigational Site | Burnsville | West Virginia | United States | 26335 |
| 749 | Pfizer Investigational Site | Lewisburg | West Virginia | United States | 24901 |
| 750 | Pfizer Investigational Site | Ronceverte | West Virginia | United States | 24970 |
| 751 | Pfizer Investigational Site | Aguas Buenas | Puerto Rico | 00703 | |
| 752 | Pfizer Investigational Site | Aguns Buenoas | Puerto Rico | 00703 | |
| 753 | Pfizer Investigational Site | Aibonito | Puerto Rico | 00705 | |
| 754 | Pfizer Investigational Site | Bayamon | Puerto Rico | 00956 | |
| 755 | Pfizer Investigational Site | Bayamon | Puerto Rico | 00959 | |
| 756 | Pfizer Investigational Site | Caguas | Puerto Rico | 00725 | |
| 757 | Pfizer Investigational Site | Carolina | Puerto Rico | 00983 | |
| 758 | Pfizer Investigational Site | Cayey | Puerto Rico | 00736 | |
| 759 | Pfizer Investigational Site | Cialis | Puerto Rico | 00638 | |
| 760 | Pfizer Investigational Site | Cidra | Puerto Rico | 00739 | |
| 761 | Pfizer Investigational Site | Hato Rey | Puerto Rico | 00918 | |
| 762 | Pfizer Investigational Site | Juncas | Puerto Rico | 00777 | |
| 763 | Pfizer Investigational Site | Juncos | Puerto Rico | 00777 | |
| 764 | Pfizer Investigational Site | Las Piedras | Puerto Rico | 00771 | |
| 765 | Pfizer Investigational Site | Levittown | Puerto Rico | 00949 | |
| 766 | Pfizer Investigational Site | Loiza | Puerto Rico | 00772 | |
| 767 | Pfizer Investigational Site | Manati | Puerto Rico | 00674 | |
| 768 | Pfizer Investigational Site | Orocovis | Puerto Rico | 00720 | |
| 769 | Pfizer Investigational Site | Rio Piedras | Puerto Rico | 00921 | |
| 770 | Pfizer Investigational Site | Rio Piedras | Puerto Rico | 00926 | |
| 771 | Pfizer Investigational Site | San Juan | Puerto Rico | 00915 | |
| 772 | Pfizer Investigational Site | San Juan | Puerto Rico | 00921-1308 | |
| 773 | Pfizer Investigational Site | San Juan | Puerto Rico | 00924 | |
| 774 | Pfizer Investigational Site | San Juan | Puerto Rico | 00927 | |
| 775 | Pfizer Investigational Site | Santa Isabel | Puerto Rico | 00757 | |
| 776 | Pfizer Investigational Site | Santurce | Puerto Rico | 00908 | |
| 777 | Pfizer Investigational Site | Trujillo Alto | Puerto Rico | 00976 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00373685
Other Study ID Numbers:
- A3191331
First Posted:
Sep 8, 2006
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Period Title: Overall Study | ||
| STARTED | 4035 | 4032 |
| Treated | 3984 | 3955 |
| COMPLETED | 2596 | 2611 |
| NOT COMPLETED | 1439 | 1421 |
Baseline Characteristics
| Arm/Group Title | Celecoxib | nsNSAIDs | Total |
|---|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing | Total of all reporting groups |
| Overall Participants | 4035 | 4032 | 8067 |
| Age, Customized (Number) [Number] | |||
| <55 years |
5
0.1%
|
2
0%
|
7
0.1%
|
| 55-59 years |
1339
33.2%
|
1361
33.8%
|
2700
33.5%
|
| 60-64 years |
1149
28.5%
|
1127
28%
|
2276
28.2%
|
| 65-69 years |
848
21%
|
822
20.4%
|
1670
20.7%
|
| 70-74 years |
504
12.5%
|
517
12.8%
|
1021
12.7%
|
| >=75 years |
184
4.6%
|
197
4.9%
|
381
4.7%
|
| Unspecified |
6
0.1%
|
6
0.1%
|
12
0.1%
|
| Sex/Gender, Customized (Number) [Number] | |||
| Male |
980
24.3%
|
962
23.9%
|
1942
24.1%
|
| Female |
3049
75.6%
|
3064
76%
|
6113
75.8%
|
| Unspecified |
6
0.1%
|
6
0.1%
|
12
0.1%
|
Outcome Measures
| Title | Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: randomized participants |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 4035 | 4032 |
| Number [Percentage of participants] |
1.3
0%
|
2.4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test | |
| Method | Life Table Extension of CMH Test | |
| Comments | ||
| Title | Percentage of Participants With Moderate to Severe Abdominal Symptoms |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 4035 | 4032 |
| Number [Percentage of participants] |
2.3
0.1%
|
3.4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0035 |
| Comments | ||
| Method | Life Table Extension of CMH Test | |
| Comments | ||
| Title | Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 4035 | 4032 |
| Number [Percentage of participants] |
2.8
0.1%
|
3.0
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6140 |
| Comments | ||
| Method | Life Table Extension of CMH Test | |
| Comments | ||
| Title | Hemoglobin (Hb) at Baseline |
|---|---|
| Description | |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N= number of evaluable participants analyzed |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3604 | 3574 |
| Mean (Standard Deviation) [gram per deciliter (g/dL)] |
13.6
(1.1)
|
13.6
(1.2)
|
| Title | Change From Baseline Hb at Week 24 |
|---|---|
| Description | |
| Time Frame | Baseline and Week 24 or ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF) |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3604 | 3574 |
| Least Squares Mean (Standard Error) [g/dL] |
-0.109
(0.012)
|
-0.241
(0.012)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value associated with Overall (LOCF) | |
| Method | ANCOVA | |
| Comments | ||
| Title | Hematocrit (Hct) at Baseline |
|---|---|
| Description | |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N= number of evaluable participants analyzed |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3596 | 3568 |
| Mean (Standard Deviation) [Percent] |
40.8
(3.4)
|
40.9
(3.4)
|
| Title | Change From Baseline Hct at Week 24 |
|---|---|
| Description | |
| Time Frame | Baseline and Week 24 or ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N= number of evaluable participants analyzed; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3596 | 3568 |
| Least Squares Mean (Standard Error) [Percent] |
-0.330
(0.038)
|
-0.716
(0.039)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | P-value associated with Overall (LOCF) | |
| Method | ANCOVA | |
| Comments | ||
| Title | Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3604 | 3574 |
| Week 8 (n= 3043, 3086) |
0.7
0%
|
0.9
0%
|
| Week 16 (n=2687, 2675) |
0.8
0%
|
1.6
0%
|
| Week 24 (n=3278, 3207) |
0.9
0%
|
1.5
0%
|
| Week 24 LOCF (n=3604, 3574) |
1.8
0%
|
2.9
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0023 |
| Comments | P-value associated with Overall (LOCF) | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3887 | 3904 |
| Baseline (n=3887, 3904) |
39.8
1%
|
38.0
0.9%
|
| Week 8 (n=3181, 3199) |
78.5
1.9%
|
69.5
1.7%
|
| Week 16 (n=2784, 2772) |
81.9
2%
|
74.6
1.9%
|
| Week 24 or ET (n=3383, 3361) |
74.6
1.8%
|
70.8
1.8%
|
| Week 24/LOCF (n=3672, 3651) |
74.5
1.8%
|
70.3
1.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1008 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 8 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 16 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24 or ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24/LOCF | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3890 | 3905 |
| Baseline (n=3890, 3905) |
43.2
1.1%
|
43.7
1.1%
|
| Week 8 (n=3185, 3202) |
80.2
2%
|
71.6
1.8%
|
| Week 16 (n=2784,2777) |
83.2
2.1%
|
77.7
1.9%
|
| Week 24 or ET (n=3386,3362) |
76.2
1.9%
|
73.8
1.8%
|
| Week 24/LOCF (n=3672, 3653) |
76.0
1.9%
|
73.3
1.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6562 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 8 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 16 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24 or ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0245 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24/LOCF | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0074 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3888 | 3905 |
| Baseline (n=3888, 3905) |
41.4
1%
|
40.5
1%
|
| Week 8 (n=3185, 3203) |
77.4
1.9%
|
69.2
1.7%
|
| Week 16 (n=2783, 2778) |
80.5
2%
|
74.5
1.8%
|
| Week 24 or ET (n=3385, 3362) |
74.0
1.8%
|
71.3
1.8%
|
| Week 24/LOCF (n=3671, 3653) |
74.0
1.8%
|
70.8
1.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4074 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 8 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 16 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24 or ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0127 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24/LOCF | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0019 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3886 | 3905 |
| Baseline (n=3886, 3905) |
37.8
0.9%
|
36.6
0.9%
|
| Week 8 (n=3182, 3202) |
75.4
1.9%
|
66.8
1.7%
|
| Week 16 (n=2780,2778) |
77.8
1.9%
|
71.6
1.8%
|
| Week 24 or ET (n=3383,3361) |
72.2
1.8%
|
68.8
1.7%
|
| Week 24/LOCF (n=3671, 3653) |
72.2
1.8%
|
68.2
1.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2699 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 8 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 16 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24 or ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0027 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Celecoxib, nsNSAIDs |
|---|---|---|
| Comments | Week 24/LOCF | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Positive Blood Fecal Occult |
|---|---|
| Description | Positive blood fecal occult; blood in feces that is not visibly apparent |
| Time Frame | Week 24 or ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 4035 | 4032 |
| Number [Percentage of participants] |
1.1
0%
|
1.4
0%
|
| Title | Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3720 | 3718 |
| PPIs |
23.0
0.6%
|
24.2
0.6%
|
| H2RAs |
5.0
0.1%
|
5.7
0.1%
|
| Gastric protective agents |
0.9
0%
|
1.0
0%
|
| Title | Percentage of Participants With Non-study Medication Utilization |
|---|---|
| Description | Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use. |
| Time Frame | Baseline through week 24 or ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; N= number of evaluable participants analyzed |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing |
| Measure Participants | 3720 | 3718 |
| Acetaminophen |
6.8
0.2%
|
6.5
0.2%
|
| Acetylsalicylic acid (ASA) |
3.5
0.1%
|
3.0
0.1%
|
| NSAIDs |
12.8
0.3%
|
13.3
0.3%
|
| Opioids |
14.2
0.4%
|
15.6
0.4%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. | |||
| Arm/Group Title | Celecoxib | nsNSAIDs | ||
| Arm/Group Description | Celecoxib open-label per United States Package Insert (US PI) recommended dosing | Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing | ||
All Cause Mortality |
||||
| Celecoxib | nsNSAIDs | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Celecoxib | nsNSAIDs | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 99/3970 (2.5%) | 95/3951 (2.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/3970 (0%) | 1/3951 (0%) | ||
| Iron deficiency anaemia | 0/3970 (0%) | 1/3951 (0%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/3970 (0%) | 0/3951 (0%) | ||
| Acute myocardial infarction | 1/3970 (0%) | 1/3951 (0%) | ||
| Atrial fibrillation | 3/3970 (0.1%) | 1/3951 (0%) | ||
| Bradycardia | 0/3970 (0%) | 1/3951 (0%) | ||
| Cardiac failure congestive | 1/3970 (0%) | 1/3951 (0%) | ||
| Coronary artery disease | 2/3970 (0.1%) | 1/3951 (0%) | ||
| Coronary artery stenosis | 1/3970 (0%) | 0/3951 (0%) | ||
| Mitral valve incompetence | 1/3970 (0%) | 0/3951 (0%) | ||
| Myocardial infarction | 3/3970 (0.1%) | 1/3951 (0%) | ||
| Myocardial ischaemia | 0/3970 (0%) | 1/3951 (0%) | ||
| Palpitations | 0/3970 (0%) | 1/3951 (0%) | ||
| Supraventricular tachycardia | 0/3970 (0%) | 1/3951 (0%) | ||
| Tachycardia | 0/3970 (0%) | 1/3951 (0%) | ||
| Tricuspid valve incompetence | 1/3970 (0%) | 0/3951 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 2/3970 (0.1%) | 1/3951 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/3970 (0.1%) | 2/3951 (0.1%) | ||
| Abdominal pain upper | 0/3970 (0%) | 1/3951 (0%) | ||
| Abdominal strangulated hernia | 0/3970 (0%) | 1/3951 (0%) | ||
| Bezoar | 1/3970 (0%) | 0/3951 (0%) | ||
| Colitis ulcerative | 1/3970 (0%) | 0/3951 (0%) | ||
| Diverticular perforation | 0/3970 (0%) | 1/3951 (0%) | ||
| Diverticulum intestinal haemorrhagic | 0/3970 (0%) | 1/3951 (0%) | ||
| Duodenal ulcer | 0/3970 (0%) | 1/3951 (0%) | ||
| Gastric ulcer | 2/3970 (0.1%) | 1/3951 (0%) | ||
| Gastritis | 0/3970 (0%) | 1/3951 (0%) | ||
| Gastrointestinal haemorrhage | 0/3970 (0%) | 2/3951 (0.1%) | ||
| Ileus | 0/3970 (0%) | 1/3951 (0%) | ||
| Inguinal hernia, obstructive | 0/3970 (0%) | 1/3951 (0%) | ||
| Large intestinal obstruction | 0/3970 (0%) | 1/3951 (0%) | ||
| Large intestine perforation | 1/3970 (0%) | 0/3951 (0%) | ||
| Nausea | 0/3970 (0%) | 1/3951 (0%) | ||
| Peptic ulcer | 1/3970 (0%) | 0/3951 (0%) | ||
| Peritonitis | 1/3970 (0%) | 0/3951 (0%) | ||
| Rectal haemorrhage | 0/3970 (0%) | 1/3951 (0%) | ||
| Small intestinal perforation | 1/3970 (0%) | 0/3951 (0%) | ||
| Vomiting | 0/3970 (0%) | 2/3951 (0.1%) | ||
| General disorders | ||||
| Asthenia | 0/3970 (0%) | 2/3951 (0.1%) | ||
| Chest pain | 10/3970 (0.3%) | 7/3951 (0.2%) | ||
| Device dislocation | 1/3970 (0%) | 0/3951 (0%) | ||
| Malaise | 1/3970 (0%) | 0/3951 (0%) | ||
| Non-cardiac chest pain | 1/3970 (0%) | 1/3951 (0%) | ||
| Pain | 1/3970 (0%) | 0/3951 (0%) | ||
| Performance status decreased | 1/3970 (0%) | 0/3951 (0%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 1/3970 (0%) | 0/3951 (0%) | ||
| Cholecystitis | 3/3970 (0.1%) | 0/3951 (0%) | ||
| Cholecystitis acute | 0/3970 (0%) | 1/3951 (0%) | ||
| Cholecystitis chronic | 1/3970 (0%) | 0/3951 (0%) | ||
| Cholelithiasis | 1/3970 (0%) | 0/3951 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 0/3970 (0%) | 3/3951 (0.1%) | ||
| Bronchitis | 1/3970 (0%) | 2/3951 (0.1%) | ||
| Bronchopneumonia | 1/3970 (0%) | 0/3951 (0%) | ||
| Cellulitis | 1/3970 (0%) | 2/3951 (0.1%) | ||
| Clostridium difficile colitis | 0/3970 (0%) | 1/3951 (0%) | ||
| Diverticulitis | 3/3970 (0.1%) | 3/3951 (0.1%) | ||
| Empyema | 0/3970 (0%) | 1/3951 (0%) | ||
| Endocarditis | 1/3970 (0%) | 0/3951 (0%) | ||
| Gastroenteritis viral | 1/3970 (0%) | 0/3951 (0%) | ||
| Localised infection | 1/3970 (0%) | 0/3951 (0%) | ||
| Mycobacterium avium complex infection | 1/3970 (0%) | 0/3951 (0%) | ||
| Pneumonia | 5/3970 (0.1%) | 3/3951 (0.1%) | ||
| Scrotal abscess | 1/3970 (0%) | 0/3951 (0%) | ||
| Urinary tract infection | 2/3970 (0.1%) | 1/3951 (0%) | ||
| Vaginal abscess | 0/3970 (0%) | 1/3951 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Bone fragmentation | 1/3970 (0%) | 0/3951 (0%) | ||
| Contusion | 0/3970 (0%) | 2/3951 (0.1%) | ||
| Heat exhaustion | 1/3970 (0%) | 0/3951 (0%) | ||
| Injury | 0/3970 (0%) | 1/3951 (0%) | ||
| Joint injury | 0/3970 (0%) | 1/3951 (0%) | ||
| Limb injury | 0/3970 (0%) | 1/3951 (0%) | ||
| Limb traumatic amputation | 0/3970 (0%) | 1/3951 (0%) | ||
| Meniscus lesion | 1/3970 (0%) | 0/3951 (0%) | ||
| Multiple injuries | 0/3970 (0%) | 1/3951 (0%) | ||
| Pelvic fracture | 0/3970 (0%) | 1/3951 (0%) | ||
| Peroneal nerve injury | 0/3970 (0%) | 1/3951 (0%) | ||
| Pneumothorax traumatic | 0/3970 (0%) | 1/3951 (0%) | ||
| Postoperative ileus | 1/3970 (0%) | 0/3951 (0%) | ||
| Renal haematoma | 0/3970 (0%) | 1/3951 (0%) | ||
| Rib fracture | 0/3970 (0%) | 1/3951 (0%) | ||
| Spinal compression fracture | 0/3970 (0%) | 1/3951 (0%) | ||
| Traumatic brain injury | 0/3970 (0%) | 1/3951 (0%) | ||
| Wrist fracture | 1/3970 (0%) | 0/3951 (0%) | ||
| Investigations | ||||
| Blood amylase increased | 1/3970 (0%) | 0/3951 (0%) | ||
| Blood glucose increased | 0/3970 (0%) | 1/3951 (0%) | ||
| Heart rate increased | 0/3970 (0%) | 1/3951 (0%) | ||
| Lipase increased | 1/3970 (0%) | 0/3951 (0%) | ||
| Liver function test abnormal | 0/3970 (0%) | 1/3951 (0%) | ||
| Occult blood positive | 1/3970 (0%) | 0/3951 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/3970 (0%) | 1/3951 (0%) | ||
| Hyperglycaemia | 1/3970 (0%) | 0/3951 (0%) | ||
| Hypokalaemia | 1/3970 (0%) | 0/3951 (0%) | ||
| Hyponatraemia | 1/3970 (0%) | 0/3951 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 0/3970 (0%) | 1/3951 (0%) | ||
| Back pain | 1/3970 (0%) | 3/3951 (0.1%) | ||
| Compartment syndrome | 0/3970 (0%) | 1/3951 (0%) | ||
| Intervertebral disc degeneration | 1/3970 (0%) | 0/3951 (0%) | ||
| Intervertebral disc displacement | 1/3970 (0%) | 0/3951 (0%) | ||
| Musculoskeletal pain | 1/3970 (0%) | 0/3951 (0%) | ||
| Osteoarthritis | 9/3970 (0.2%) | 3/3951 (0.1%) | ||
| Spinal column stenosis | 1/3970 (0%) | 1/3951 (0%) | ||
| Spinal osteoarthritis | 0/3970 (0%) | 1/3951 (0%) | ||
| Colon cancer | 0/3970 (0%) | 1/3951 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma | 1/3970 (0%) | 0/3951 (0%) | ||
| B-cell lymphoma | 1/3970 (0%) | 0/3951 (0%) | ||
| Basal cell carcinoma | 2/3970 (0.1%) | 1/3951 (0%) | ||
| Basosquamous carcinoma | 1/3970 (0%) | 0/3951 (0%) | ||
| Breast cancer | 4/3970 (0.1%) | 2/3951 (0.1%) | ||
| Colon adenoma | 0/3970 (0%) | 1/3951 (0%) | ||
| Endometrial cancer | 0/3970 (0%) | 1/3951 (0%) | ||
| Lung neoplasm malignant | 0/3970 (0%) | 1/3951 (0%) | ||
| Malignant melanoma | 1/3970 (0%) | 0/3951 (0%) | ||
| Meningioma | 0/3970 (0%) | 1/3951 (0%) | ||
| Myeloid leukaemia | 1/3970 (0%) | 0/3951 (0%) | ||
| Pancreatic carcinoma | 1/3970 (0%) | 0/3951 (0%) | ||
| Salivary gland neoplasm | 0/3970 (0%) | 1/3951 (0%) | ||
| Squamous cell carcinoma | 4/3970 (0.1%) | 1/3951 (0%) | ||
| Transitional cell carcinoma | 0/3970 (0%) | 1/3951 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 2/3970 (0.1%) | 2/3951 (0.1%) | ||
| Cervicobrachial syndrome | 1/3970 (0%) | 0/3951 (0%) | ||
| Dizziness | 0/3970 (0%) | 2/3951 (0.1%) | ||
| Loss of consciousness | 1/3970 (0%) | 1/3951 (0%) | ||
| Lumbar radiculopathy | 0/3970 (0%) | 1/3951 (0%) | ||
| Paraesthesia | 0/3970 (0%) | 3/3951 (0.1%) | ||
| Sciatica | 1/3970 (0%) | 0/3951 (0%) | ||
| Syncope | 1/3970 (0%) | 1/3951 (0%) | ||
| Thrombotic stroke | 0/3970 (0%) | 1/3951 (0%) | ||
| Transient ischaemic attack | 1/3970 (0%) | 1/3951 (0%) | ||
| Psychiatric disorders | ||||
| Completed suicide | 1/3970 (0%) | 0/3951 (0%) | ||
| Depression | 1/3970 (0%) | 1/3951 (0%) | ||
| Panic attack | 1/3970 (0%) | 0/3951 (0%) | ||
| Suicidal ideation | 0/3970 (0%) | 1/3951 (0%) | ||
| Renal and urinary disorders | ||||
| Calculus ureteric | 1/3970 (0%) | 2/3951 (0.1%) | ||
| Hydronephrosis | 0/3970 (0%) | 1/3951 (0%) | ||
| Incontinence | 1/3970 (0%) | 0/3951 (0%) | ||
| Nephrocalcinosis | 0/3970 (0%) | 1/3951 (0%) | ||
| Nephrolithiasis | 2/3970 (0.1%) | 0/3951 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/3970 (0%) | 0/3951 (0%) | ||
| Ovarian cyst | 0/3970 (0%) | 1/3951 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/3970 (0%) | 1/3951 (0%) | ||
| Chronic obstructive pulmonary disease | 5/3970 (0.1%) | 2/3951 (0.1%) | ||
| Cough | 1/3970 (0%) | 0/3951 (0%) | ||
| Dyspnoea | 1/3970 (0%) | 0/3951 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/3970 (0%) | 0/3951 (0%) | ||
| Surgical and medical procedures | ||||
| Breast lump removal | 1/3970 (0%) | 0/3951 (0%) | ||
| Colectomy | 0/3970 (0%) | 1/3951 (0%) | ||
| Coronary artery bypass | 1/3970 (0%) | 0/3951 (0%) | ||
| Foot amputation | 0/3970 (0%) | 1/3951 (0%) | ||
| Hip arthroplasty | 0/3970 (0%) | 1/3951 (0%) | ||
| Knee arthroplasty | 0/3970 (0%) | 2/3951 (0.1%) | ||
| Spinal laminectomy | 1/3970 (0%) | 0/3951 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 0/3970 (0%) | 1/3951 (0%) | ||
| Aortic stenosis | 1/3970 (0%) | 0/3951 (0%) | ||
| Arteriosclerosis obliterans | 0/3970 (0%) | 1/3951 (0%) | ||
| Deep vein thrombosis | 1/3970 (0%) | 1/3951 (0%) | ||
| Hypertension | 2/3970 (0.1%) | 0/3951 (0%) | ||
| Hypotension | 0/3970 (0%) | 1/3951 (0%) | ||
| Intermittent claudication | 0/3970 (0%) | 1/3951 (0%) | ||
| Peripheral vascular disorder | 0/3970 (0%) | 1/3951 (0%) | ||
| Thrombophlebitis | 0/3970 (0%) | 1/3951 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Celecoxib | nsNSAIDs | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 962/3970 (24.2%) | 1163/3951 (29.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 30/3970 (0.8%) | 52/3951 (1.3%) | ||
| Abdominal pain | 37/3970 (0.9%) | 59/3951 (1.5%) | ||
| Abdominal pain upper | 37/3970 (0.9%) | 60/3951 (1.5%) | ||
| Constipation | 36/3970 (0.9%) | 70/3951 (1.8%) | ||
| Diarrhoea | 84/3970 (2.1%) | 115/3951 (2.9%) | ||
| Dyspepsia | 65/3970 (1.6%) | 98/3951 (2.5%) | ||
| Gastritis | 32/3970 (0.8%) | 39/3951 (1%) | ||
| Gastrooesophageal reflux disease | 29/3970 (0.7%) | 78/3951 (2%) | ||
| Nausea | 65/3970 (1.6%) | 112/3951 (2.8%) | ||
| General disorders | ||||
| Oedema peripheral | 50/3970 (1.3%) | 67/3951 (1.7%) | ||
| Infections and infestations | ||||
| Bronchitis | 86/3970 (2.2%) | 77/3951 (1.9%) | ||
| Sinusitis | 75/3970 (1.9%) | 88/3951 (2.2%) | ||
| Upper respiratory tract infection | 112/3970 (2.8%) | 75/3951 (1.9%) | ||
| Urinary tract infection | 70/3970 (1.8%) | 75/3951 (1.9%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 44/3970 (1.1%) | 64/3951 (1.6%) | ||
| Investigations | ||||
| Haemoglobin decreased | 59/3970 (1.5%) | 84/3951 (2.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 82/3970 (2.1%) | 73/3951 (1.8%) | ||
| Back pain | 42/3970 (1.1%) | 43/3951 (1.1%) | ||
| Osteoarthritis | 29/3970 (0.7%) | 39/3951 (1%) | ||
| Pain in extremity | 59/3970 (1.5%) | 47/3951 (1.2%) | ||
| Nervous system disorders | ||||
| Dizziness | 43/3970 (1.1%) | 51/3951 (1.3%) | ||
| Headache | 67/3970 (1.7%) | 83/3951 (2.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 42/3970 (1.1%) | 41/3951 (1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 40/3970 (1%) | 44/3951 (1.1%) | ||
| Vascular disorders | ||||
| Hypertension | 35/3970 (0.9%) | 45/3951 (1.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00373685
Other Study ID Numbers:
- A3191331
First Posted:
Sep 8, 2006
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021