drugset / Trial / NCT00586365

Naproxen for the Prevention of HO After Complex Elbow Trauma

NCT00586365

Phase 4 Withdrawn Massachusetts General Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2007-10
Primary completion
2010-01
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Naproxen Small molecule 500 mg