Naproxen for the Prevention of HO After Complex Elbow Trauma

This study has been withdrawn prior to enrollment.
(Too difficult to satisfy all the inclusion criteria.)
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00586365
First received: December 14, 2007
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Heterotopic Ossification
Drug: Naproxen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • There is no difference in ulnohumeral flexion [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  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: NCT00586365

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

Publications:
Responsible Party: David C. Ring, MD, Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00586365     History of Changes
Other Study ID Numbers: 2006-P-001670
Study First Received: December 14, 2007
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
complex elbow trauma
prevention
complication
naproxen
NSAIDS

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

ClinicalTrials.gov processed this record on September 30, 2014