E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
calcific tendonitis of the rotator cuff |
tendinopatia calcifica della spalla |
|
E.1.1.1 | Medical condition in easily understood language |
calcific tendonitis of the rotator cuff |
tendinopatia calcifica della spalla |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of clinically significant difference (according to the scale of Constant) for a single injection of cortisone intrabursale post-TPE; |
Valutare se esiste una differenza clinicamente significativa (secondo la scala di Constant) ad una singola somministrazione intrabursale di cortisonico post-TPE; |
|
E.2.2 | Secondary objectives of the trial |
A) evaluate the sonographic appearance with clinical improvement;
B) assess the prevalence and duration of inhibition of the HPA axis resulting in intrabursale single injection of cortisone (triamcinolone acetonide or methylprednisolone);
C) to correlate the plasma levels of corticosteroid (triamcinolone acetonide or methylprednisolone) with indices of adrenal function. |
A) valutare l’aspetto ecografico con il miglioramento clinico;
B) valutare la prevalenza e la durata dell’inibizione dell’asse HPA conseguente a singola iniezione intrabursale di cortisonico (triamcinolone acetonide o metilprednisolone);
C) correlare i livelli plasmatici di cortisonico (triamcinolone acetonide o metilprednisolone) con gli indici di funzionalità surrenalica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes, aged between 30-50 years, suffering from painful calcific tendonitis of the shoulder (calcification or mature phase of resorption) confirmed by ultrasound examination. |
Pazienti di entrambi i sessi, di età compresa fra i 30-50 anni, affetti da tendinopatia calcifica dolorosa della spalla (calcificazione matura o in fase di riassorbimento) confermata con indagine ecografica. |
|
E.4 | Principal exclusion criteria |
• enthesitis calcific shoulder
• calcific tendinopathy with lesions of the rotator cuff
• Septic arthritis or infection of the superficial tissues or periarticular
• Disease hematologic or coagulation (liver failure ....)
• metabolic diseases (diabetes)
• Glaucoma
• Organ Transplant
• collagenopatiche diseases or systemic inflammatory rheumatic (SLE, RA ..)
• previous use of cortisone 2 months prior to TPE
• Concomitant therapy with anticoagulants and / or antiplatelet
• A history of asthma, allergic rhinitis, allergic conjunctivitis, bronchiectasis, sarcoidosis (erythema nodosum, uveitis ..), cystic fibrosis, COPD, Crohn's, ulcerative colitis
• are allergic to cortisone derivatives
• Pregnant or lactating
• Minors |
• Entesite calcifica della spalla
• Tendinopatia calcifica con lesione della cuffia dei rotatori
• Artrite settica o infezione dei tessuti superficiali o periarticolari
• Malattia ematologica o di coagulazione (insufficienza epatica….)
• Malattie dismetaboliche (diabete)
• Glaucoma
• Trapianto d’organo
• Malattie collagenopatiche o infiammatorie sistemiche di tipo reumatico (LES, AR..)
• Pregresso uso di cortisonico 2 mese prima dalla T.P.E
• Terapia concomitante con anticoagulanti e/o antiaggreganti
• Anamnesi positiva per asma, rinite allergica, congiuntivite allergica, bronchiectasie, sarcoidosi (eritema nodoso, uveite..), fibrosi cistica, BPCO, Crohn, colite ulcerosa
• allergia a derivati cortisonici
• Gravide o in fase di allattamento
• Minorenni |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of clinically significant difference (according to the scale of Constant) for a single injection of cortisone intrabursale post-TPE; |
Valutare se esiste una differenza clinicamente significativa (secondo la scala di
Constant) ad una singola somministrazione intrabursale di cortisonico post-TPE; |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 30 post treatment TPE |
30° giorno post trattamento TPE |
|
E.5.2 | Secondary end point(s) |
A) evaluate the sonographic appearance with clinical improvement;
B) assess the prevalence and duration of inhibition of the HPA axis resulting in
intrabursale single injection of corticosteroid (triamcinolone acetonide or methylprednisolone);
C) to correlate the plasma levels of corticosteroid (triamcinolone acetonide or methylprednisolone) with
indices of adrenal function. |
A) valutare l’aspetto ecografico con il miglioramento clinico;
B) valutare la prevalenza e la durata dell’inibizione dell’asse HPA conseguente a
singola iniezione intrabursale di cortisonico (triamcinolone acetonide o metilprednisolone);
C) correlare i livelli plasmatici di cortisonico (triamcinolone acetonide o metilprednisolone) con
gli indici di funzionalità surrenalica. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 45 post treatment TPE |
45° giorno post trattamento TPE |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Systematic assessment of inhibition hypothalamic-pituitary-adrenal |
Valutazione sistematica dell’inibizione asse ipotalamo-ipofisi-surrene |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |