Multicentre, prospective, double-blind, in parallel groups, randomized, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic lateral epicondylitis (tennis elbow)
- Conditions
- Chronic Lateral Elbow TendinopathyMedDRA version: 17.1Level: LLTClassification code 10043258Term: Tennis elbowSystem Organ Class: 100000004863MedDRA version: 17.1Level: LLTClassification code 10024032Term: Lateral epicondylitisSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-004119-35-IT
- Lead Sponsor
- IBSA Institut Biochimique SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.outpatients of both genders, aged =18 years;
2.patients suffering from chronic (i.e., for =12 weeks) Lateral Elbow Tendinopathy (MedDRA version 17.0, LLT Classification code: 10024032 = Lateral epicondylitis; 10043258 = Tennis elbow), being confirmed through a clinical diagnosis;
3.patients in their symptomatic phase, defined as a pain =50 mm on a 0-100 mm Visual Analogue Scale as perceived when performing a standardized movement (according to Cozen’s or Mill’s test);
4.written informed consent to participate in the study obtained according to GCP;
5.patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects and patients able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement;
6.female subjects of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline*.
*Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1.patients having received a local injection of corticosteroid for their tendinopathy or an intra-articular (any joint) corticosteroid injection <6 months before inclusion, or a local corticosteroid injection for medical conditions other than the one under investigation <1 month before inclusion;
2.patients having taken systemic anti-inflammatory steroidal drugs <1 month before inclusion;
3.patients having taken systemic NSAIDs (e.g. ibuprofen, ketoprofen) <48 hours (paracetamol permitted), or long-acting NSAIDs (piroxicam or naproxen), opioids and narcotic analgesics <7 days before inclusion, or patients under chronic treatment with topical or systemic analgesics/NSAIDs;
4.patients having undergone a standard physiotherapeutic treatment (except for cold or hot patch application and/or use of braces for casting), an electro-medical Tecar therapy, a Laser therapy, Iontophoresis therapy or Eccentric Training for the treatment of their tendinopathy <3 months before inclusion;
5.patients presenting signs and symptoms suggestive of another cause for their pain in the affected area (e.g. congenital or acquired structural or neurological abnormalities, chronic joint diseases, possible traumatic or neoplastic origin of symptoms, bilateral complaints);
6.patients having undergone a previous surgical treatment in the affected area, or a surgical treatment planned in the 6 weeks following the inclusion;
7.patients having fractures, dislocations, calcifications or ruptures of tendon in the affected area;
8.patients with history of previous fractures or ruptures of tendon in the affected area;
9.patients with systemic musculoskeletal disease or neurological disorder which the Investigator considers to potentially affect the outcome of the study;
10.patients with skin lesions or dermatological diseases in the affected area that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy).
Additional exclusion criteria will be:
11.allergy to the active substance or excipients contained in the tested medication (particularly betamethasone valerate, methyl parahydroxybenzoate and propyl-parahydroxybenzoate) or to the rescue medication (paracetamol);
12.history of anaphylaxis to drugs or allergic reactions in general which the Investigator considers to potentially affect the outcome of the study;
13.presence of severe cardiac, liver or kidney dysfunction;
14.underlying disease or medication that severely compromise the subject's immune system (T-lymphocytes impairment or immunosuppressive therapy) and that, in the view of the Investigator, could compromise the patient’s participation in the study;
15.patients with clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters;
16.patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study;
17.patients with history of alcohol or drug abuse (within previous 12 months);
18.pregnant or breast-feeding women;
19.patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects and patients unable to cooperate with the Investigator and to comply with the requirement of the entire study (including inability to attend all the planned study visits according to t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method