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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00533377 |
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
Condition | Intervention | Phase |
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Tibial Fractures |
Drug: CP-533, 536 Drug: Placebo Procedure: Standard of Care Drug: CP-533,536 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of CP-533,536 In Subjects With Closed Fracture Of The Tibial Shaft |
Estimated Enrollment: | 264 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CP-533,536 Dose Level 2: Experimental |
Drug: CP-533, 536
Active study drug
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo vehicle
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Standard of Care |
Procedure: Standard of Care
Standard surgical procedure
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CP-533,536 Dose Level 1: Experimental |
Drug: CP-533,536
Active study drug
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Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3241010 |
Study First Received: | September 20, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00533377 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Fractures, Closed Leg Injuries Tibial Fractures |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries Tibial Fractures |