NCT01631669

Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification. H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification

Detailed description

This study is a prospective, randomized, controlled clinical trial.

Conditions

• Ossification, Heterotopic

Interventions

Type	Name	Description
DRUG	Celecoxib	200 mg Q 12 hours orally

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-06-01
• Completion: 2018-06-01
• First posted: 2012-06-29
• Last updated: 2012-07-03

Locations

2 sites across 2 countries: United States, Germany