ALGRX 4975 in the Treatment of Tennis Elbow

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AlgoRx Pharmaceuticals

Criteria

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.