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The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-533,536 Dose Level 2 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Standard of Care | Other |
| |
| CP-533,536 Dose Level 1 | Experimental |
| |
| CP-533,536 Dose Level 3 | Experimental |
| |
| CP-533.536 Dose Level 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-533, 536 | Drug | Active study drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fracture healing compared with placebo | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who require a secondary intervention to promote fracture healing | 48 weeks | |
| Impact on the subject's ability to return to normal function, general health status, work productivity, and degree of pain at fracture site compared with placebo and Standard of Care groups |
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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 | Wichita | Kansas | 67214 | United States | ||
| 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 |
Placebo vehicle |
|
| Standard of Care | Procedure | Standard surgical procedure |
|
| CP-533,536 | Drug | Active study drug |
|
| CP-533,536 | Drug | Active study drug |
|
| CP-533,536 | Drug | Active study drug |
|
| 24 weeks |
| Time to fracture healing compared with Standard of Care | 24 weeks |
| Proportion of patients healed compared with placebo | 16 weeks |
| Time to regular callus formation compared with placebo | 24 weeks |
| Worcester |
| Massachusetts |
| 01655 |
| United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55415 | United States |
| Pfizer Investigational Site | Columbia | Missouri | 65212 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37403 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84108 | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | 26505 | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | 26506 | United States |
| Pfizer Investigational Site | Herston | Queensland | 4029 | Australia |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Sarajevo | 71000 | Bosnia and Herzegovina |
| Pfizer Investigational Site | Red Deer | Alberta | T4N 4E7 | Canada |
| Pfizer Investigational Site | Red Deer | Alberta | T4N 6V7 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8L 2X2 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4G5 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 5W9 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4P3 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4R9 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 6H3 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 6H5 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 6H6 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 6S3 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T G6G | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5B 1W8 | Canada |
| Pfizer Investigational Site | Varaždin | 42000 | Croatia |
| Pfizer Investigational Site | Zagreb | 10000 | Croatia |
| Pfizer Investigational Site | Secunderabad | Andhra Pradesh | 500 003 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 001 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Mangalore | Karnataka | 575 001 | India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 012 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141008 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226003 | India |
| Pfizer Investigational Site | Nagoya | Aichi-ken | Japan |
| Pfizer Investigational Site | Kitakyushu-shi | Fukuoka | Japan |
| Pfizer Investigational Site | Mizumaki-cho Onga-gun | Fukuoka | Japan |
| Pfizer Investigational Site | Okawa-shi | Fukuoka | Japan |
| Pfizer Investigational Site | Fujisawa-shi | Kanagawa | Japan |
| Pfizer Investigational Site | Kouchi | Kouchi-ken | Japan |
| Pfizer Investigational Site | Sasebo-Shi | Nagasaki | Japan |
| Pfizer Investigational Site | Toda-shi | Saitama | Japan |
| Pfizer Investigational Site | Shinagawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Saint Petersburg | 193312 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 195427 | Russia |
| Pfizer Investigational Site | Parktown | Gauteng | 2193 | South Africa |
| Pfizer Investigational Site | Glenwood | KwaZulu-Natal | 4000 | South Africa |
| Pfizer Investigational Site | Soweto | 2013 | South Africa |
| Pfizer Investigational Site | Tygerberg | 7505 | South Africa |
| Pfizer Investigational Site | Seville | Sevilla | 41013 | Spain |
| Pfizer Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Pfizer Investigational Site | Izmir | 35100 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C475539 | CP533536 |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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