Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003207-37

A.3

Full 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.3.1

Title 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.

A.4.1

Sponsor's protocol code number

750/11

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Policlinico Universitario Agostino Gemelli
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Policlinico Gemelli
B.5.2	Functional name of contact point	Unita' operativa di ortopedia
B.5.3	Address:
B.5.3.1	Street Address	Lgo Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630154353
B.5.5	Fax number	063051161
B.5.6	E-mail	deriulaura@yahoo.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ORTHOVISC SIR 2ML 15MG/ML 1PZ
D.2.1.1.2	Name of the Marketing Authorisation holder	VITA RESEARCH Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HYALURONIC ACID
D.3.9.1	CAS number	9004-61-9
D.3.9.4	EV Substance Code	SUB14126MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DEPOMEDROL*1FL 40MG 1ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METHYLPREDNISOLONE ACETATE
D.3.9.1	CAS number	53361
D.3.9.4	EV Substance Code	SUB03255MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

ROTATOR CUFF TENDINOPATHY

tendinopatia cuffia dei rotatori

E.1.1.1

Medical condition in easily understood language

ROTATOR CUFF TENDINOPATHY

tendinopatia cuffia dei rotatori

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	PT
E.1.2	Classification code	10039227
E.1.2	Term	Rotator cuff syndrome
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

1-3-6 months

1-3-6 mesi

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women 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.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-20

P. End of Trial
P.	End of Trial Status	Ongoing

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