Acute Lateral Epicondylitis (tennis elbow) MedDRA version: 7.0 Level: HLT Classification code 10024032
Conditions
Interventions
Product Name: ALGRX 4975
Product Code: ALGRX 4975
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Capsaicin, Ultra-purified
CAS Number: 404-86-4
Current Sponsor code
Sponsors
AlgoRx Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of either gender, aged 18 - 75 years. 2. Subjects with acute lateral epicondylitis (LE) of less than 3 months’ duration (subjects with recurrent acute LE may be included) with the following characteristics: ? pain on palpation of the epicondyle and/or the common extensor mass ? pain on wrist pronation and dorsiflexion against resistance with the elbow in extension ? pain reproduced by static stretching of the pronated wrist in palmar flexion with the elbow in extension ? Normal anterior-posterior and lateral X-ray films of the elbow 3. Subjects with a screening (Visit 1) and baseline (Visit 2) severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity. 4. Subjects who are lidocaine responsive, as confirmed by an injection of lidocaine to the most tender spot at the screening visit. Only subjects who are totally pain free 15 minutes after the injection of lidocaine (2.5 mL of 2% lidocaine) will be allowed to enter the study. If the patient remains pain free at the baseline visit, he/she will not be eligible to participate in the study. 5. The subject has a systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively 6. Subjects who have provided written informed consent which has been approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB). 7. Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal. 8. Ability to understand the requirements of the study, abide by the study restrictions and agree to return for the required assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a clinically significant form of joint disease at the elbow, other than acute LE. 2. Subjects with a history of elbow trauma in the last 2 years. 3. Subjects who are undergoing physiotherapy treatment within the preceding 2 weeks, prior to Visit 1. 4. Subjects with a history of rheumatoid, inflammatory, degenerative, polyarthritis, metabolic/crystal-induced or infectious arthritis, or carpal tunnel syndrome. 5. Subjects who have received any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at ? 1000 ?g/day. 6. The subject has a medical condition other then LE that requires the use of a pain medication (e.g., fibromyalgia, inflammatory arthritis, musculoskeletal or articular disorder or any congenital, direct traumatic, crystal-induced, metabolic, infectious or immune-related disorder). 7. The subject has a medical condition that in the Investigator’s opinion could adversely impact their participation or safety, conduct of the study, or interfere with the pain assessments. 8. The subject has active cutaneous infection, trauma, or clinically significant form of disease at the anticipated site of injection. 9. The subject used an analgesic, other than aspirin for cardiovascular prophylaxis, during the washout period that could confound the analgesic response. 10. Subjects with any neuromuscular disorder affecting the area, including radial or ulnar nerve entrapment, or tumor. 11. Subjects in whom the use of lidocaine, capsaicin or paracetamol is contraindicated (e.g., significant history of allergic reactions or intolerance to these or related substances). 12. The subject has a peripheral sensory or motor neuropathy involving the upper extremities. 13. The subject is taking an antihypertensive agent, antidepressant, or anticonvulsant that has not been stable for at least 2 months. 14. The subject is diabetic and has not been on a stable diabetic regimen for the past 2 months. 15. Female subjects who are pregnant or lactating. 16. Female subjects of childbearing potential who are not practicing an effective method of contraception. 17. The subject has taken any investigational medication within 3 months prior to the first dose of study drug (Visit 2), or is scheduled to receive an investigational drug other than ALGRX 4975 while participating in the study. 18. Subjects who have previously entered this study. 19. The subject has a history of drug or alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a single dose of ALGRX 4975 in subjects with recent onset of acute lateral epicondylitis.;Secondary Objective: To evaluate the safety and determine the duration of effect of a single dose of ALGRX 4975;Primary end point(s): The primary endpoint will be the pain induced by resisted wrist dorsiflexion (0=no pain, 1=full movement possible but slight pain, 2=movement possible but moderate pain, 3=movement possible but marked pain, 4=pain prevents any degree of resisted movement) 4 weeks after treatment. Pain induced by wrist dorsiflexion at other timepoints will be a secondary endpoint. | — |
Countries
Slovakia
Outcome results
None listed