Chronic Lateral Elbow Tendinopathy MedDRA version: 17.1 Level: LLT Classification code 10043258 Term: Tennis elbow System Organ Class: 100000004863 MedDRA version: 17.1 Level: LLT Classification code 10024032 Term: Lateral epicondylitis System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Betesil 2,250 mg medicated plaster
Product Name: Medicated plaster containing Betamethasone valerate 2.25 mg
Pharmaceutical Form: Cutaneous patch
Pharmaceutical form of the placebo: Cutane
Sponsors
IBSA Institut Biochimique SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Summed Pain Intensity Difference (SPID), defined as the sum of differences at each pre-defined control visit during the treatment period, as compared to pre-treatment level, based on the patient’s evaluations as described above for the primary endpoint; • Mean Daily Pain Level, based on patient’s diary VAS pain evaluations, and calculated as average between the morning VAS pain value and the evening VAS pain value; • Morning Pain Level, based on patient diary VAS pain evaluations in the morning immediately before plaster application; • Evening Pain Level, based on patient diary VAS pain evaluations in the evening (immediately before plaster removal); • Patient's self-perceived Level of Improvement as compared to their pre-treatment status at inclusion will be assessed at each control visit by means a 6-points Likert scale with the following categories: completely recovered/ much improved/ improved/ no change/ worse/ much worse; • Proportion (%) of Successes at the ‘end-of-treatment’ visit (Day 28), based on patient's assessment of self-perceived level of improvement. The two top categories completely recovered and much improved of the 6-point Likert scale will be dichotomised as 'success', while the other categories will be collapsed to represent 'no-success'; • Functional Disability, as assessed by the patient by means of the Patient-Rated Tennis Elbow Evaluation (PRTEE) score at ‘end-of-treatment’ visit, compared to the pre-treatment score; • Overall Treatment Efficacy, judged by the Investigator at ‘end-of-treatment’ visit, by means of a 5-point scale (4=excellent; 3=good; 2=fair; 1=poor; 0=none); • Total dose (n. of tablets) of Rescue Medication (paracetamol) used, as well as the proportion of patients using the rescue medication during the study. In order to assess the treatment’s safety, the following endpoints will be considered: • Adverse Events (AEs) and Treatment Emergent AEs (TEAEs), occurring at any time during the stu | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the ability of betamethasone valerate 2.25 mg medicated plaster, as compared to placebo plaster (same formulation but without active ingredient), to significantly reduce pain in patients suffering from chronic lateral elbow tendinopathy, when topically applied daily, according to a 12 hours of application/day dose regimen, and during a period of 4 weeks.;Secondary Objective: Secondary objectives of the study are the evaluation of the local tolerability at the site of plaster application, with particular attention to any atrophic change of the skin, and the appreciation of the general safety of the tested medication.;Primary end point(s): Pain Reduction at Day 28 (V5) post-baseline control visit, as compared to the pre-treatment pain level at the inclusion, as scored by the patient using a 0-100 mm Visual Analogue Scale (VAS) anchored by 'no pain' (0 mm) and 'worst imaginable pain' (100 mm) while performing a standardized movement (according to Cozen’s or Mill’s test).;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Italy
Contacts
Public ContactR&D Dept.
IBSA Institut Biochimique SA
Outcome results
None listed