ALGRX 4975 in the Treatment of Tennis Elbow

December 18, 2006 updated by: AlgoRx Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Phase II, Exploratory Evaluation of ALGRX 4975 in Subjects With Acute Lateral Epicondylitis

Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. This study will test the efficacy and safety of ALGRX 4975 in the treatment of patients with tennis elbow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per 1000 annually and tends to involve the subject's dominant side. It typically results from repetitive arm movement with over use of muscles leading to small tears in the tendons attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on or around the lateral epicondyle may radiate down the subject's arm. Gripping or extending the wrist often intensifies the pain.

More than 40 possible treatments have been proposed, reflecting a lack of consensus about optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat tennis elbow, but there are no trials to date that have compared them with other painkillers and one study found no clinically important benefit over placebo. Use of corticosteroid injections provides mixed results in relief of pain and at times insufficient evidence to support their use. Although complications associated with steroid injection are relatively uncommon, when a complication does occur, it can result in severe and disabling consequences for the subject. A small proportion of subjects fail to respond to only one injection of corticosteroid and some subjects who initially improved at four weeks had worse symptoms by six months.

This study has been designed to evaluate the safety and efficacy of a single soft tissue injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute LE.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Kosice, Slovakia, 040 11
        • Ortopedicko-Traumatologicka Klinika

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute lateral epicondylitis (LE) of less than 3 months duration (subjects with recurrent acute LE may be included).
  • A screening and baseline severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
  • Lidocaine responsive.
  • A systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively.

Exclusion Criteria:

  • Any clinically significant form of joint disease, elbow trauma or neuromuscular disorder at the elbow, other than acute LE.
  • Physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
  • Any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at less than or equal to 1000 mcg/day.
  • A medical condition other than LE that requires the use of a pain medication.
  • A peripheral sensory or motor neuropathy involving the upper extremities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Grip strength
Pain induced by resisted wrist dorsiflexion (other than 4 weeks)
Pain experienced during the grip strength test
Pain in elbow over previous 24 hours
Effect on work
Tenderness elicited by investigator or designee
Subjects' global impression of change
Secondary outcomes are evaluated at 1, 2, 4, 8 and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlgoRx Pharmaceuticals

Investigators

  • Principal Investigator: Gabriel Vasko, MD PhD, Ortopedicko-Traumatologicka Klinika, Kosice, Slovak Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 17, 2005

Study Record Updates

Last Update Posted (Estimate)

December 20, 2006

Last Update Submitted That Met QC Criteria

December 18, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4975-2-005-2
  • Eudra CT No : 2004-001000-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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