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Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

NCT01631669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-07-03

No results posted yet for this study

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

Conditions

  • Ossification, Heterotopic

Interventions

DRUG

Celecoxib

200 mg Q 12 hours orally

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Jonathan A Forsberg, MD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-06-30
Completion
2018-06-30

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631669 on ClinicalTrials.gov