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    Summary
    EudraCT Number:2011-003207-37
    Sponsor's Protocol Code Number:750/11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003207-37
    A.3Full title of the trial
    COMPARISON BETWEEN INTRA-ARTICULAR INJECTION OF CORTICOSTEROIDS AND INTRA-ARTICULAR INJECTION OF HYALURONIC ACID IN THE TREATMENT OF ROTATOR CUFF TENDINOPATHY. A PROSPECTIVE CLINICAL TRIAL.
    CONFRONTO TRA TERAPIA INFILTRATIVA CON CORTICOSTEROIDI E TERAPIA INFILTRATIVA CON ACIDO IALURONICO NEL TRATTAMENTO DELLA TENDINOPATIA DELLA CUFFIA DEI ROTATORI. STUDIO CLINICO PROSPETTICO RANDOMIZZATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARISON BETWEEN INTRA-ARTICULAR INJECTION OF CORTICOSTEROIDS AND INTRA-ARTICULAR INJECTION OF HYALURONIC ACID IN THE TREATMENT OF ROTATOR CUFF TENDINOPATHY. A PROSPECTIVE CLINICAL TRIAL.
    CONFRONTO TRA TERAPIA INFILTRATIVA CON CORTICOSTEROIDI E TERAPIA INFILTRATIVA CON ACIDO IALURONICO NEL TRATTAMENTO DELLA TENDINOPATIA DELLA CUFFIA DEI ROTATORI. STUDIO CLINICO PROSPETTICO RANDOMIZZATO
    A.4.1Sponsor's protocol code number750/11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPoliclinico Universitario Agostino Gemelli
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoliclinico Gemelli
    B.5.2Functional name of contact pointUnita' operativa di ortopedia
    B.5.3 Address:
    B.5.3.1Street AddressLgo Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630154353
    B.5.5Fax number063051161
    B.5.6E-mailderiulaura@yahoo.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ORTHOVISC SIR 2ML 15MG/ML 1PZ
    D.2.1.1.2Name of the Marketing Authorisation holderVITA RESEARCH Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYALURONIC ACID
    D.3.9.1CAS number 9004-61-9
    D.3.9.4EV Substance CodeSUB14126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DEPOMEDROL*1FL 40MG 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE ACETATE
    D.3.9.1CAS number 53361
    D.3.9.4EV Substance CodeSUB03255MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ROTATOR CUFF TENDINOPATHY
    tendinopatia cuffia dei rotatori
    E.1.1.1Medical condition in easily understood language
    ROTATOR CUFF TENDINOPATHY
    tendinopatia cuffia dei rotatori
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039227
    E.1.2Term Rotator cuff syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to evaluate the differences between intra-articular injection with corticosteroids and hyaluronic acid in the treatment of rotator cuff tendinopathy at a short-term follow-up
    valutare le differenze di risultato clinico a breve termine tra terapia infiltrativa con corticosteroidi e terapia infiltrativa con acido ialuronico nel trattamento delle tendinopatie croniche della cuffia dei rotatori.
    E.2.2Secondary objectives of the trial
    Secondary outcomes of the study include:
    - Evaluation of differences of the global health status of the affected shoulder with a specific scoring system (Constant-Murley score).
    - Evaluation of differences in pain with a Visual Analogic Scale (VAS score).
    Valutazione della differenza nello stato funzionale globale della spalla affetta mediante sistema di valutazione funzionale specifico per la spalla (punteggio di Constant-Murley).
    - Valutazione della differenza nella sintomatologia dolorosa residua mediante scala analogica visiva (punteggio VAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive subacromial impingment tests (Neer’s test and Hawkin’s test)
    - Degenerative changes of rotator cuff tendons with no loss of continuity and/or subacromial bursitis, investigated with a MRI study
    - Signing an agreement disclosure form.
    Positività ai test clinici di impingement subacromiale (Test di Neer e Test di Hawkins)
    - Presenza di alterazioni degenerative in continuità dei tendini della cuffia dei rotatori e/o borsite subacromiale, diagnosticate mediante esame RMN.
    - Previa accettazione ad entrare nello studio mediante sottoscrizione di uno specifico consenso informato.
    E.4Principal exclusion criteria
    - Full-thickness tear of rotator cuff
    - Antero-superior cuff tear, involving the subscapularis tendon
    - Labral pathology amenable to surgical repair (i.e. gleno-humeral instability associated to rotator cuff tendinopathy, SLAP lesions
    - Os acromiale
    - Degenerative arthritis of the glenohumeral joint,
    - Symptomatic arthritis of acromioclavicular joint,
    - Previous surgery on the same shoulder
    - Workers’ Compensation claims
    - Neurological diseases involving the shoulder girdle (i.e. axillary nerve tears, syringomyelia)
    - Systemic inflammatory diseases
    - Pathologies for which cortcosteroid are contraindicated (i.e. diabetes mellitus, hypercortisolism, peptic ulcer).
    - Tumor or metastatic disease
    - Heart diseases
    - Active infection or bone TB
    - Pregnancy.
    - Acute skin disease
    - Predictable poor compliance to treatment
    - Difficulty in completing questionnaires.
    Lesioni a tutto spessore della cuffia dei rotatori.
    - Lesioni della cuffia antero-superiore coinvolgenti il tendine del sottoscapolare.
    - Presenza di patologia capsulo-labrale associata, suscettibile di trattamento chirurgico (ad. esempio instabilità gleno-omerale associata a tendinopatia della cuffia dei rotatori, lesioni SLAP).
    - Presenza di un os acromiale.
    - Artrosi dell’articolazione gleno-omerale.
    - Artrosi sintomatica dell’articolazione acromion-claveare.
    - Precedenti interventi chirurgici alla stessa spalla.
    - Sindrome da risarcimento.
    - Patologia neurologica che coinvolge gli arti superiori (ad esempio lesioni del nervo ascellare, siringomielia).
    - Patologie infiammatorie a carattere sistemico.
    8
    - Patologie concomitanti per le quali è controindicato il trattamento cortisonico (ad es. diabete mellito, ipercortisolismo, ulcera peptica)
    - Neoplasie
    - Pazienti cardiopatici.
    - Pazienti con infezioni acute o TBC ossea.
    - Pazienti in gravidanza.
    - Pazienti con affezioni dermatologiche acute.
    - Scarsa compliance del paziente al trattamento.
    - Difficoltà a completare i questionari.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome will be measured with the validated Italian version of DASH questionnaire (Disability of Arm, Shoulder and Hand), in its shortened version (Quick-DASH).
    L’outcome primario utilizzato per confrontare i due trattamenti oggetto di studio è la versione italiana validata del questionario DASH (Disability of Arm, Shoulder and Hand) nella sua versione ridotta (Quick-DASH). Tale questionario autosomministrato è realizzato per valutare la qualità di vita in pazienti con patologie dell’arto superiore. Esso misura specificamente la disabilità del paziente ed è basato su 11 domande a risposta multipla con un punteggio, per ciascuna domanda, che varia da 1 a 5. Il punteggio totale viene aritmeticamente convertito sulla base di una scala che va da 0 (disabilità minima, miglior risultato) a 100 (disabilità massima, peggior risultato). Tale questionario si è dimostrato valido, affidabile e responsivo in popolazioni di pazienti simili a quella del presente studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3-6 months
    1-3-6 mesi
    E.5.2Secondary end point(s)
    Secondary outcome is the Constant Score, introduced by the ESSSE (European Society for Surgery of the Shoulder and the Elbow) to evaluate the function of the shoulder. The Constant score consists of four variables: pian, ADL, range of motion and strenght. Total score ranges from 0 to 100 points and it can be pondered for age and sex, based on specific conversion tables.
    Other secondary outcome is the evaluation of pain using a Visual Analog Scale (VAS) based on a metric scale ranging from 0 (no pain) to 100 points (extreme pain). Patient assigns the score independently.
    Un outcome secondario è il punteggio di Constant adottato dalla ESSSE (European Society for Surgery of the Shoulder and the Elbow) per la valutazione clinica funzionale globale della spalla. Il punteggio di Constant è basato su 4 sezioni che registrano separatamente il dolore, la capacità di svolgere attività della vita quotidiana, il range di movimento e la forza. Il punteggio totale, basato su una scala da 0 a 100 punti può essere quindi normalizzato per età e sesso, sulla base di apposite tabelle di conversione.
    Un altro outcome secondario è la valutazione della sintomatologia dolorosa mediante scala analogica visiva (VAS) basata su una scala decimale dove 0 corrisponde all’assenza di dolore e 10 al maggior dolore possibile. Il paziente dovrà attribuire un punteggio su questa scala in modo autonomo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3-6 months
    1-3-6 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 61
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state92
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 92
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    na
    na
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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