Multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of two different treatment regimens of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic tendinopathies of the upper and lower limbs

• Conditions: Chronic Lateral Elbow Tendinopathy and Chronic Midportion (or non-insertional) Achilles Tendinopathy; MedDRA version: 14.1Level: LLTClassification code 10050471Term: Achilles tendon painSystem Organ Class: 100000004859; MedDRA version: 14.1Level: LLTClassification code 10043258Term: Tennis elbowSystem Organ Class: 100000004863; MedDRA version: 14.1Level: LLTClassification code 10000441Term: Achilles tendonitisSystem Organ Class: 100000004859; MedDRA version: 14.1Level: LLTClassification code 10024032Term: Lateral epicondylitisSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005030-11-IT
• Lead Sponsor: IBSA INSTITUT BIOCHIMIQUE SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects (outpatients) of both gender, aged =18 years 2. suffering =12 weeks either from Chronic Lateral Elbow Tendinopathy (MedDRA version 15.1, LLT Classification code: 10024032 = Lateral epicondylitis; 10043258 = Tennis elbow) or Chronic Midportion (or non-insertional) Achilles Tendinopathy (MedDRA version 15.1, LLT Classification code: 10000441 = Achilles tendonitis; 10050471 = Achilles tendon pain), being confirmed through an ultrasound echographic scan, will be screened for participation. 3. Patients should be 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, identified as the most painful one according to the tendinopathy localisation 4. Patient should have given a valid written informed consent to participate in the study. 5. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

1. patients with chronic insertional Achilles tendinopathy; 2. patients having received a local corticosteroid injection for their tendinopathy or an intra-articular corticosteroid injection <6 months before inclusion; 3. 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; 4. patients having taken systemic anti-inflammatory steroidal drugs or having received local corticosteroid injection for medical conditions other than the one under investigation <1 months before inclusion; 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; 5. patients presenting signs and symptoms suggestive of another cause for their pain, congenital or acquired structural or neurological abnormalities of the limb area, chronic joint diseases, possible traumatic or neoplastic origin of symptoms, bilateral complaints, referred pain from internal organs, previous surgical treatment on the limb area (or surgical treatment planned in the 6 weeks following the inclusion); 6. patients having fractures, dislocations, calcifications or ruptures of tendon in the affected limb area (the presence of these conditions should be investigated by ultrasonography (US) examination at inclusion visit); 7. patients with history of previous fractures or ruptures of tendon in the affected limb area; 8. patients with systemic musculoskeletal disease or neurological disorder; 9. patients with presence of skin lesions or dermatological diseases that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy). 10. allergy to the active substance or excipients contained in the tested medication or to the rescue medication (paracetamol); 11. underlying disease or medication that severely compromise the subject's immune system 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. pregnant or breast-feeding women; 15. concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs during 3 months before this study or previous participation in the same study; 16. patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects, because of psycho-social or other reasons, 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 the time limits); 17. patients with history of alcohol or drug abuse (within previous 12 months); 18. patients with clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters; 19. 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 i

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified