Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Walter Reed National Military Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01631669
First received: June 27, 2012
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Ossification, Heterotopic
Drug: Celecoxib

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Incidence and severity of HO


Secondary Outcome Measures:
  • Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celebrex
Receive Celebrex
Drug: Celecoxib
200 mg Q 12 hours orally
Other Name: Celebrex
No Intervention: Control
no placebo administered

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631669

Contacts
Contact: Jonathan A Forsberg, MD 301-319-3403 jonathan.forsberg@med.navy.mil
Contact: Frederick A Gage 301-319-8592 frederick.gage@med.navy.mil

Locations
United States, Maryland
Walter Reen National Military Medical Center Bethesda Recruiting
Bethesda, Maryland, United States, 20889
Contact: Jonathan A Forsberg, MD    301-319-3403    jonathan.forsberg@med.navy.mil   
Contact: Frederick A Gage    301-319-8592    frederick.gage@med.navy.mil   
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         
Germany
Landstuhl Military Medical Center Recruiting
Landstuhl, Germany
Contact: Brett Freedman, MD       brett.freedman@amedd.army.mil   
Principal Investigator: Brett Freedman, MD         
Sub-Investigator: Hunter Martin, PhD         
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Jonathan A Forsberg, MD Walter Reed National Military Medical Center
  More Information

Publications:
Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01631669     History of Changes
Other Study ID Numbers: 352511, 110587
Study First Received: June 27, 2012
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed National Military Medical Center:
Ossification
Heterotopic Ossification

Additional relevant MeSH terms:
Ossification, Heterotopic
Pathologic Processes
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014