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

NCT01525043 | Completed Phase 4

• 1 other identifier: SYN-EPI-2011
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epicondylitis of the Elbow

Keywords

Epicondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain quality assessment scale

  Every visit from the entry

Study Arms (3)

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

Interventions

Naproxen DRUG

Naproxen 500mg BID for the first 2 weeks

Naproxen

Synera patch twice daily DRUG

1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks

Synera sinlgle patch applied for 4hrs twice daily

Synera patch for 12hrs/day DRUG

1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks

Synera single patch applied for 12 hrs/day

Synera DRUG

Topical appication of single patch to elbow for 12hrs/day

Synera single patch applied for 12 hrs/day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
• Age 18 or higher
• Minimum of 4 on Question 5 of BPI

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Clinical Research Institute: lead

Study Sites (1)

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

Location

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 2, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)