Status:
COMPLETED
ALGRX 4975 in the Treatment of Tennis Elbow
Lead Sponsor:
AlgoRx Pharmaceuticals
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
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 move...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00130949
Start Date
November 1 2004
End Date
November 1 2005
Last Update
December 20 2006
Active Locations (1)
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1
Ortopedicko-Traumatologicka Klinika
Košice, Slovakia, 040 11