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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01525043
Other study ID # SYN-EPI-2011
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2012
Last updated March 4, 2014
Start date February 2012
Est. completion date September 2013

Study information

Verified date March 2014
Source International Clinical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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:

1. 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

2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow

3. Naproxen Sodium: 500mg bid


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naproxen
Naproxen 500mg BID for the first 2 weeks
Synera patch twice daily
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
Synera patch for 12hrs/day
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
Naproxen
500mg bid
Synera
Topical appication of single patch to elbow for 12hrs/day
Synera
Single patch applied to elbow for 4hrs/twice daily

Locations

Country Name City State
United States International Clinical Research Institute Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
International Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Recruiting NCT06440928 - Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis N/A
Not yet recruiting NCT05238090 - Efficacy of a Stretching Protocol for Lateral Epicondylitis N/A
Recruiting NCT06442618 - Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial N/A
Completed NCT02710682 - Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis N/A
Completed NCT03788161 - Virtual Reality and Post-dry Needling Soreness N/A
Completed NCT04856228 - Radial Tunnel Syndrome in Resistant Lateral Epicondylitis N/A