Epicondylitis of the Elbow Clinical Trial
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
Verified date | March 2014 |
Source | International Clinical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | September 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Individuals with clinical evidence of lateral or medial epicondylitis of the elbow. - Age 18 or higher - Minimum of 4 on Question 5 of BPI Exclusion Criteria: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
United States | International Clinical Research Institute | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
International Clinical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 1 and Day 14 | |
Secondary | Pain quality assessment scale | It is a vlaidated measure to assess the qulaity of scale | Every visit from the entry |
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