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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00586365 |
Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.
Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.
The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.
Condition | Intervention | Phase |
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Heterotopic Ossification |
Drug: Naproxen |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial |
Estimated Enrollment: | 60 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Will receive 500 mg Naproxen twice a day for two weeks
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Drug: Naproxen
500 mg Naproxen twice a day for two weeks
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2: No Intervention
Will not receive naproxen
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Operative treatment of one of the following injuries
Exclusion Criteria:
An existing diagnosis of one of the following conditions
Concomitant use of one of the following drugs:
Contact: Kim M Brouwer, MSc | 6716432144 | kbrouwer@partners.org |
Contact: David Ring, MD, PHd | 6176432144 | dring@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Kim M Browuer, MSc 617-643-2144 kbrouwer@partners.org | |
Sub-Investigator: Kim M Brouwer, MSc | |
Principal Investigator: David Ring, MD, PhD |
Study Director: | David Ring, MD PhD | Mass General |
Responsible Party: | Massachusetts General Hospital ( David Ring ) |
Study ID Numbers: | 2006-P-001670 |
Study First Received: | December 14, 2007 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00586365 |
Health Authority: | United States: Institutional Review Board |
complex elbow trauma prevention complication naproxen NSAIDS |
Naproxen Wounds and Injuries Ossification, Heterotopic |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions Pathologic Processes |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |