Heterotopic OssificationPhase 4NaproxenNCT00586365
Naproxen for the Prevention of HO After Complex Elbow Trauma
A Phase 4 study testing Naproxen in people with Heterotopic Ossification, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heterotopic Ossification
- What is being tested?
- Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years or greater
- 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
Who cannot join
- 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
Show all 22Show fewer
- Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs
- Considerable dehydration
- Pregnant or breast-feeding women
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
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.
- Conditions
- Heterotopic Ossification
- Being tested
- Naproxen
- Keywords
- complex elbow trauma, prevention, complication, naproxen, NSAIDS
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
500 mg Naproxen twice a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Will receive 500 mg Naproxen twice a day for two weeks Receives: Drug: Naproxen |
| 2 | No intervention | Will not receive naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is no difference in ulnohumeral flexion
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionOct 2010
Why it stopped: Too difficult to satisfy all the inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heterotopic OssificationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD PhD, Study director, Mass General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586365
- Sponsor's protocol ID
- 2006-P-001670
- Acronym
- Naproxen
- Status last verified
- Mar 2012
- First submitted
- 14 Dec 2007
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. doi: 10.1097/00003086-200001000-00008.
PubMed 10660703
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00586365
- Acronym / sponsor ID
- Naproxen / 2006-P-001670
- Conditions
- Heterotopic Ossification
- Keywords
- complex elbow trauma, prevention, complication, naproxen, NSAIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too difficult to satisfy all the inclusion criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NaproxenWill receive 500 mg Naproxen twice a day for two weeks |
| 2 | No intervention | –Will not receive naproxen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 18 years or greater
- Operative treatment of one of the following injuries
Key exclusion criteria (22 listed)
- An existing diagnosis of one of the following conditions
- Pregnant or breast-feeding women
- Concomitant use of one of the following drugs:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen500 mg Naproxen twice a day for two weeks | Drug | 1 |
Primary outcome
There is no difference in ulnohumeral flexion
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Background: PubMed 10660703Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. doi: 10.1097/00003086-200001000-00008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD PhD study director
Mass General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen in people with Heterotopic Ossification, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There is no difference in ulnohumeral flexion (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.