Recruiting

Celecoxib

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT01631669

Conditions

Ossification, Heterotopic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Celecoxib

Study Details

Brief 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

Study ID

NCT01631669

Start date

May, 2012

Status verified date

Jun, 2012

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Celebrex

Receive Celebrex

no intervention: Control

no placebo administered

Interventions

Celecoxib

200 mg Q 12 hours orally

Primary outcome measure

  • Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Walter Reen National Military Medical Center Bethesda

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Principal Investigator:

Jonathan A Forsberg, MD

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Jul 3, 2012

Last verified

Jun, 2012

Keywords

  • Ossification
  • Heterotopic Ossification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2012-07-03.