Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
85
Countries
1
Sites
1
lateral epicondylitis
To assess the efficacy of mesotherapy with intradermal piroxicam and lidocaine delivered in comparison with dry needling for the treatment of lateral epicondylitis (LE).
Key facts
- Sponsor
- Unidade Local De Saude De Santa Maria E.P.E., Instituto De Medicina Molecular Joao Lobo Antunes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 10 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519158-34-00
- EudraCT number
- 2021-006462-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To assess the efficacy of mesotherapy with intradermal piroxicam and
lidocaine delivered in comparison with dry needling for the treatment of
lateral epicondylitis (LE).
Secondary objectives 1
- Identify clinical, functional, ultrasonographic and biochemical predictors of treatment success/failure and clinical relapse. To assess the safety of mesotherapy with intradermal piroxican and lidocaine delivered in comparison with dry needling for the treatment of LE.
Conditions and MedDRA coding
lateral epicondylitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients older than 18 years with 1) clinical diagnosis of LE defined as pain over the lateral epicondyle provoked by palpation, resisted extension or gripping; 2) A visual analogue scale (VAS) score for pain greater than 40mm (0-100mm); 3) symptoms duration for more than 3 months.
Exclusion criteria 1
- 1) other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intraarticular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions; 2) VAS score for pain less than 40mm; 3) any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these; 4) nonsteroidal anti-inflammatory drugs (NSAIDS) taken during the week previous to inclusion; 5) pregnancy; 6) allergy to any of the study drugs; 7) severely immunosuppressed patients; 8) known coagulopathies.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes from baseline in pain intensity quantified by using a 0-100 VAS score. We will consider the treatment effective if a reduction of 20/100 in the VAS score is achieved.
Secondary endpoints 1
- - Changes from baseline in a three-point scale that measures pain on resisted dorsiflexion of the wrist and third finger, registered as none, some or definite, at 1 week, 2 weeks, 3 weeks, 1 month and 3 months. - Changes from baseline in general health evaluation with the short form-36 mental health (SF- 36 MH), at 1 week, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRADERMAL USE
- Max daily dose
- 1.5 ml millilitre(s)
- Max total dose
- 1.5 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09936MIG · Substance
- Active substance
- Piroxicam
- Pharmaceutical form
- TABLET
- Route of administration
- INTRADERMAL USE
- Max daily dose
- 20 mg/ml milligram(s)/millilitre
- Max total dose
- 20 mg/ml milligram(s)/millilitre
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Unidade Local De Saude De Santa Maria E.P.E.
- Sponsor organisation
- Unidade Local De Saude De Santa Maria E.P.E.
- Address
- Avenida Professor Egas Moniz
- City
- Lisbon
- Postcode
- 1649-035
- Country
- Portugal
Scientific contact point
- Organisation
- Unidade Local De Saude De Santa Maria E.P.E.
- Contact name
- Centro Investigação Clinica
Public contact point
- Organisation
- Unidade Local De Saude De Santa Maria E.P.E.
- Contact name
- Centro Investigação Clinica
Instituto De Medicina Molecular Joao Lobo Antunes
- Sponsor organisation
- Instituto De Medicina Molecular Joao Lobo Antunes
- Address
- Avenida Professor Egas Moniz
- City
- Lisbon
- Postcode
- 1649-028
- Country
- Portugal
Sponsor responsibilities
- Article 77 compliance
- Unidade Local De Saude De Santa Maria E.P.E.
- Contact point sponsor
- Unidade Local De Saude De Santa Maria E.P.E.
- Article 77 implementation
- Unidade Local De Saude De Santa Maria E.P.E.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ongoing, recruiting | 85 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Portugal | 2025-01-10 | 2025-01-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MILES PROTOCOLO 17 08 2022 Clean | 1.1 |
| Protocol (for publication) | MILES PROTOCOLO v 1 1 30dec2024 | 1.1 |
| Recruitment arrangements (for publication) | MODALIDADE DE RECRUTAMENTO | 1 |
| Subject information and informed consent form (for publication) | CI CEIC MILES 17 08 2022 Clean | 1.01 |
| Summary of Product Characteristics (SmPC) (for publication) | Lidocaina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PiroxicamRCM | 1 |
| Synopsis of the protocol (for publication) | SINOPSE | 1 |
| Synopsis of the protocol (for publication) | SINOPSE v1 2 CLEAN | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-09 | Portugal | Acceptable 2025-01-08
|
2025-01-09 |