Chronic Lateral Elbow Tendinopathy and Chronic Midportion (or non-insertional) Achilles Tendinopathy MedDRA version: 14.1 Level: LLT Classification code 10050471 Term: Achilles tendon pain System Organ Class: 100000004859 MedDRA version: 14.1 Level: LLT Classification code 10043258 Term: Tennis elbow System Organ Class: 100000004863 MedDRA version: 14.1 Level: LLT Classification code 10000441 Term: Achilles tendonitis System Organ Class: 100000004859 MedDRA version: 14.1 Level: LLT Classifi
Conditions
Interventions
Trade Name: BETESIL*4CER MED 2,250MG
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: BETAMETHASONE VALERATE
CAS Number: 2152-44-5
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
IBSA INSTITUT BIOCHIMIQUE SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
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 reduce pain when topically applied daily, according to two different dose regimens (i.e., 12 or 24 hours of application/day), and during a period of 4 weeks, in patients suffering from chronic lateral elbow tendinopathy and chronic midportion Achilles tendinopathy.;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 the standardized movement, according to their tendinopathy localisation.;Timepoint(s) of evaluation of this end point: Pail level perceived by the patient at Day 28, will be comparated with basal assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Summed Pain Intensity Difference (SPID); • Mean Daily Pain Level; • Morning Pain Level; • Evening Pain Level • Patient's self-perceived Level of Improvement • Proportion (%) of Successes at the ‘end-of-treatment’ visit (Day 28), • Functional Disability, • Overall Treatment Efficacy, judged by the Investigator at ‘end-of-treatment’ visit • Total dose (n. of tablets) of Rescue Medication (paracetamol) used • Pre-/post-treatment changes in pre-specified intra-tendineous US scan criteria reflecting tissue degeneration and inflammation The primary efficacy parameter, pre-/post-treatment pain reduction, and SPID will also be separately analysed for each of the 2 affected areas (i.e. elbow, Achilles tendon) for explorative purposes, in order to identify any possible difference in clinical effects potentially related to the plaster’s application site. • Adverse Events (AEs) and Treatment Emergent AEs (TEAEs), occurring at any time during the study. • Vital Signs (blood pressure, heart rate) • Skin irritation at the plaster application site • Presence of visible atrophic changes of the skin at the plaster application site • Overall Treatment Tolerability, independently judged by the Investigator and the patient, at the ‘end-of-treatment visit’ FOR EXPLANATION ABOUT EACH END-POINT SEE THE STUDY PROTOCOL;Timepoint(s) of evaluation of this end point: Evaluations will be done within the end of the study, 28 Days ±2, according to study protocol. | — |
Countries
Italy
Contacts
Public ContactR&D Dept.
IBSA Institut Biochimique SA
Outcome results
None listed