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Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

Information source: International Clinical Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epicondylitis of the Elbow

Intervention: Naproxen (Drug); Synera patch twice daily (Drug); Synera patch for 12hrs/day (Drug); Naproxen (Drug); Synera (Drug); Synera (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: International Clinical Research Institute

Official(s) and/or principal investigator(s):
Srinivas Nalamachu, MD, Principal Investigator, Affiliation: International Clinical Research Institute, Inc.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Pain quality assessment scale

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: 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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

International Clinical Research Institute, Overland Park, Kansas 66210, United States
Additional Information

Starting date: February 2012
Last updated: March 4, 2014

Page last updated: August 23, 2015

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