Epicondylitis of the ElbowPhase 4NCT01525043
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
A Phase 4 study testing Naproxen, Synera patch twice daily and Synera patch for 12hrs/day in people with Epicondylitis of the Elbow, run by International Clinical Research Institute at 1 site in United States.
Trial summary
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Epicondylitis of the Elbow
- What is being tested?
- Naproxen, Synera patch twice daily and Synera patch for 12hrs/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2013
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
- Age 18 or higher
- Minimum of 4 on Question 5 of BPI
Who cannot join
- Peripheral neuropathy of any origin in the index limb
- Cubital tunnel syndrome in patients with medial epicondylitis
- Cortisone injection in the last 4 weeks into the index limb
- Surgical intervention in the past for the epicondiitis
- Participants in any other clinical trial in the last 30 days
- Known allergy to lidocaine, tetracaine, NSAIDs or PABA
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- Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator
- Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias
- Patients who are pregnant, lactating or breast feeding
- Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Clinical Research Institute
Overland Park, Kansas, 66210
About this study
Official title: Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.
Read the detailed description
The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:
- Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
- Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
- Naproxen Sodium: 500mg bid
- Conditions
- Epicondylitis of the Elbow
- Being tested
- Naproxen, Synera patch twice daily, Synera patch for 12hrs/day, Synera
- Keywords
- Epicondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Naproxen 500mg BID for the first 2 weeks
Synera patch twice dailyDrug
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
Synera patch for 12hrs/dayDrug
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
NaproxenDrug
500mg bid
SyneraDrug
Topical appication of single patch to elbow for 12hrs/day
SyneraDrug
Single patch applied to elbow for 4hrs/twice daily
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| Synera single patch applied for 12 hrs/day | Experimental | Not described Receives: Drug: Synera patch for 12hrs/day; Drug: Synera |
| Synera sinlgle patch applied for 4hrs twice daily | Experimental | Not described Receives: Drug: Synera patch twice daily; Drug: Synera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit
Measured: Day 1 and Day 14
Secondary outcomes (1)
Pain quality assessment scale
It is a vlaidated measure to assess the qulaity of scale
Measured: Every visit from the entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis of the ElbowStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srinivas Nalamachu, MD, Principal investigator, International Clinical Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525043
- Sponsor's protocol ID
- SYN-EPI-2011
- Status last verified
- Mar 2014
- First submitted
- 30 Jan 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow
- ClinicalTrials.gov ID
- NCT01525043
- Acronym / sponsor ID
- SYN-EPI-2011
- Conditions
- Epicondylitis of the Elbow
- Keywords
- Epicondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- International Clinical Research InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Feb 2012 (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.
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.
Detailed description
The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:
- Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
- Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
- Naproxen Sodium: 500mg bid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Active comparator | Drug: Naproxen |
| Synera single patch applied for 12 hrs/day | Experimental | Drug: Synera patch for 12hrs/day, Drug: Synera |
| Synera sinlgle patch applied for 4hrs twice daily | Experimental | Drug: Synera patch twice daily, Drug: Synera |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
- Age 18 or higher
- Minimum of 4 on Question 5 of BPI
Key exclusion criteria (10 listed)
- Peripheral neuropathy of any origin in the index limb
- Cubital tunnel syndrome in patients with medial epicondylitis
- Cortisone injection in the last 4 weeks into the index limb
- Surgical intervention in the past for the epicondiitis
- Participants in any other clinical trial in the last 30 days
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 |
|---|---|---|
| NaproxenNaproxen 500mg BID for the first 2 weeks | Drug | Naproxen |
| Synera patch twice daily1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks | Drug | Synera sinlgle patch applied for 4hrs twice daily |
| Synera patch for 12hrs/day1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks | Drug | Synera single patch applied for 12 hrs/day |
| Naproxen500mg bid | Drug | Naproxen |
| SyneraTopical appication of single patch to elbow for 12hrs/day | Drug | Synera single patch applied for 12 hrs/day |
| SyneraSingle patch applied to elbow for 4hrs/twice daily | Drug | Synera sinlgle patch applied for 4hrs twice daily |
Primary outcome
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
Time frame: Day 1 and Day 14
Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit
1 secondary outcome
Pain quality assessment scale
Time frame: Every visit from the entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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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.
Srinivas Nalamachu, MD principal investigator
International Clinical Research Institute, Inc.
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, Synera patch twice daily and Synera patch for 12hrs/day in people with Epicondylitis of the Elbow, run by International Clinical Research Institute 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 5 Mar 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily (time frame: Day 1 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2014.