Naproxen for the Prevention of HO After Complex Elbow Trauma (Naproxen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586365
Recruitment Status : Withdrawn (Too difficult to satisfy all the inclusion criteria.)
First Posted : January 4, 2008
Last Update Posted : March 21, 2012
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

Brief Summary:

Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.

Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.

The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.

Condition or disease Intervention/treatment Phase
Heterotopic Ossification Drug: Naproxen Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
Study Start Date : October 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Will receive 500 mg Naproxen twice a day for two weeks
Drug: Naproxen
500 mg Naproxen twice a day for two weeks
No Intervention: 2
Will not receive naproxen

Primary Outcome Measures :
  1. There is no difference in ulnohumeral flexion [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Subjects aged 18 years or greater
  2. Operative treatment of one of the following injuries

    • An elbow dislocation with or without associated fractures
    • An olecranon fracture-dislocation, but not simple olecranon fractures
    • A distal humerus fracture

Exclusion Criteria:

  1. An existing diagnosis of one of the following conditions

    • Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications
    • Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion
    • History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding
    • Impaired renal function (creatinine > 2.0), hypovolemia, heart failure, high blood pressure ( > 160/90), fluid retention, asthma, liver dysfunction (bilirubin > 2.0), or a coagulation disorder
    • Allergy to non-steroidal anti-inflammatory medications
    • Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs
    • Considerable dehydration
  2. Pregnant or breast-feeding women
  3. Concomitant use of one of the following drugs:

    • Aspirin
    • Other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve)
    • Methotrexate
    • Diuretics (thiazides / furosemide)
    • ACE-inhibitors (captopril, enalapril, ramipril etc.)
    • Beta-blockers (propanolol etc.)
    • Probenecid (for gout or hyperuricemia)
    • H2-blockers, sucralfate and intensive antacid therapy
    • Lithium
    • Anticoagulants / Warfarin (coumadin, waran, jantoven etc.)
    • Sulfonamides
    • Anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586365

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Study Director: David Ring, MD PhD Mass General

Responsible Party: David C. Ring, MD, Director of Research, Hand Service, Massachusetts General Hospital Identifier: NCT00586365     History of Changes
Other Study ID Numbers: 2006-P-001670
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
complex elbow trauma

Additional relevant MeSH terms:
Ossification, Heterotopic
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action