Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
This study is currently recruiting participants.
Verified June 2012 by Walter Reed National Military Medical Center
Sponsor:
Walter Reed National Military Medical Center
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
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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 ]
- Overall rate of impaired wound healing.
- Overall time to fracture union (if applicable)
- Overall rate of nonunions (if applicable)
- 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:
- ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
- Extremity Wound ≥75cm2 requiring operative intervention
- Minimal age of 18 years
Exclusion Criteria:
The following co-morbidities will result in exclusion from study:
- Coronary Artery Disease,
- Diabetes Mellitus (IDDM or T2DM),
- Peripheral Vascular Disease,
- Age >65,
- Connective tissue disorders,
- Immunosuppression,
- Clinically-evident peptic ulcer disease,
- Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
- 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,
- Severe penetrating or hemorrhagic traumatic brain injury,
- Endoscopic gastrointestinal interventions,
- Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
- Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
- History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
- Hepatic Impairment
- Warfarin
- Lithium
- Drugs known to inhibit CYP2C9 Liver Enzymes
- Subjects known or suspected to be poor CYP2C9 metabolizers
- Concomitant use with ACE Inhibitors and Angiotension II Antagonists
Contacts and Locations
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 Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013