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| ID | Type | Description | Link |
|---|---|---|---|
| A3191098 |
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To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg oral capsule once daily for 12 weeks |
| |
| Celecoxib |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in global pain intensity as assessed by visual analog scale (VAS) | Week 12 | |
| Responder rates, defined as 50% improvement in VAS from baseline | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's and physician's global assessment of disease activity | Weeks 1, 2, 6, and 12 | |
| Spinal pain | Weeks 1, 2, 6, and 12 | |
| Short Form-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aachen | 52064 | Germany | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
200 mg oral capsule twice daily for 12 weeks |
|
| Diclofenac | Drug | 75 mg oral capsule twice daily for 12 weeks |
|
| Weeks 1, 2, 6, and 12 |
| Adverse events | Week 12 |
| Physical evaluation | Week 12 |
| Laboratory tests | Week 12 |
| Nocturnal pain | Weeks 1, 2, 6, and 12 |
| Composite Bath Ankylosing Spondylitis Disease Activity Index | Weeks 1, 2, 6, and 12 |
| Bath Ankylosing Spondylitis Metrology Index | Weeks 1, 2, 6, and 12 |
| Change from baseline in C-reactive protein measurement | Week 12 |
| Responder rates, defined as 50% improvement in VAS from baseline | Weeks 1, 2, and 6 |
| Mobility parameters | Weeks 1, 2, 6, and 12 |
| Change from baseline in Assessments in Ankylosing Spondylitis 20 score | Weeks 1, 2, 6, and 12 |
| Change from baseline in global pain intensity | Weeks 1, 2, and 6 |
| Bath Ankylosing Spondylitis Functional Index | Weeks 1, 2, 6, and 12 |
| Bad Aibling |
| 83043 |
| Germany |
| Pfizer Investigational Site | Bad Iburg | 49186 | Germany |
| Pfizer Investigational Site | Bad Münder am Deister | 31848 | Germany |
| Pfizer Investigational Site | Berlin | 10559 | Germany |
| Pfizer Investigational Site | Berlin | 10777 | Germany |
| Pfizer Investigational Site | Berlin | 12200 | Germany |
| Pfizer Investigational Site | Berlin | 12247 | Germany |
| Pfizer Investigational Site | Berlin | 13125 | Germany |
| Pfizer Investigational Site | Berlin | 14059 | Germany |
| Pfizer Investigational Site | Berlin | D-10098 | Germany |
| Pfizer Investigational Site | Bonn | 53179 | Germany |
| Pfizer Investigational Site | Celle / OT Klein Hehlen | 29223 | Germany |
| Pfizer Investigational Site | Chemnitz | 09130 | Germany |
| Pfizer Investigational Site | Cologne | 51107 | Germany |
| Pfizer Investigational Site | Darmstadt | 64295 | Germany |
| Pfizer Investigational Site | Dresden | Germany |
| Pfizer Investigational Site | Düsseldorf | 40211 | Germany |
| Pfizer Investigational Site | Elmshorn | 25335 | Germany |
| Pfizer Investigational Site | Erlangen | 91056 | Germany |
| Pfizer Investigational Site | Halle | 06128 | Germany |
| Pfizer Investigational Site | Hanover | 30161 | Germany |
| Pfizer Investigational Site | Heidelberg | 69120 | Germany |
| Pfizer Investigational Site | Hildesheim | 31134 | Germany |
| Pfizer Investigational Site | Hofheim | 65719 | Germany |
| Pfizer Investigational Site | Hoyerswerda | 02977 | Germany |
| Pfizer Investigational Site | Leipzig | 04107 | Germany |
| Pfizer Investigational Site | Leverkusen | 51373 | Germany |
| Pfizer Investigational Site | Magdeburg | 39104 | Germany |
| Pfizer Investigational Site | Mannheim | 68165 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | Neubrandenburg | 17033 | Germany |
| Pfizer Investigational Site | Oldenburg | 26121 | Germany |
| Pfizer Investigational Site | Osnabrück | 49074 | Germany |
| Pfizer Investigational Site | Pirna | 01796 | Germany |
| Pfizer Investigational Site | Ratingen | D40882 | Germany |
| Pfizer Investigational Site | Regensburg | Germany |
| Pfizer Investigational Site | Remscheid | 42897 | Germany |
| Pfizer Investigational Site | Rheine | 48431 | Germany |
| Pfizer Investigational Site | Rostock | 18059 | Germany |
| Pfizer Investigational Site | Saarbrücken | 66111 | Germany |
| Pfizer Investigational Site | Seesen | 38723 | Germany |
| Pfizer Investigational Site | Surwold | 26903 | Germany |
| Pfizer Investigational Site | Tübingen | 72076 | Germany |
| Pfizer Investigational Site | Villingen-Schwenningen | 78054 | Germany |
| Pfizer Investigational Site | Weener | 26826 | Germany |
| Pfizer Investigational Site | Winsen | 21423 | Germany |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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