Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

June 29, 2012 updated by: Walter Reed National Military Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Landstuhl, Germany
        • Recruiting
        • Landstuhl Military Medical Center
        • Contact:
        • Principal Investigator:
          • Brett Freedman, MD
        • Sub-Investigator:
          • Hunter Martin, PhD
  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Recruiting
        • Walter Reen National Military Medical Center Bethesda
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan A Forsberg, MD
        • Sub-Investigator:
          • Benjamin K Potter, MD
        • Sub-Investigator:
          • Eric A Elster, MD
        • Sub-Investigator:
          • Frederick A Gage
        • Sub-Investigator:
          • Felipe Lisboa, MD
        • Sub-Investigator:
          • Tala Ghadimi, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
  2. Extremity Wound ≥75cm2 requiring operative intervention
  3. Minimal age of 18 years

Exclusion Criteria:

The following co-morbidities will result in exclusion from study:

  1. Coronary Artery Disease,
  2. Diabetes Mellitus (IDDM or T2DM),
  3. Peripheral Vascular Disease,
  4. Age >65,
  5. Connective tissue disorders,
  6. Immunosuppression,
  7. Clinically-evident peptic ulcer disease,
  8. Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
  9. Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
  10. Severe penetrating or hemorrhagic traumatic brain injury,
  11. Endoscopic gastrointestinal interventions,
  12. Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
  13. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
  14. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
  15. Hepatic Impairment
  16. Warfarin
  17. Lithium
  18. Drugs known to inhibit CYP2C9 Liver Enzymes
  19. Subjects known or suspected to be poor CYP2C9 metabolizers
  20. Concomitant use with ACE Inhibitors and Angiotension II Antagonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celebrex
Receive Celebrex
Drug: Celecoxib
200 mg Q 12 hours orally
Other Names:
  • Celebrex
No Intervention: Control
no placebo administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Time Frame: 3 years
Incidence and severity of HO
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Time Frame: 3 years
  1. Overall rate of impaired wound healing.
  2. Overall time to fracture union (if applicable)
  3. Overall rate of nonunions (if applicable)
  4. Overall rate of drug-related complications
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Investigators

  • Principal Investigator: Jonathan A Forsberg, MD, Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 352511
  • 110587 (Other Identifier: FDA IND)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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