Clinical Trials Register

Summary
EudraCT Number:	2011-005661-20
Sponsor's Protocol Code Number:	SKP-021-01-11
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-23
Trial results	View 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

2011-005661-20

A.3

Full title of the trial

A double-blind, randomised, parallel group, active controlled, multicentre study to assess the therapeutic non-inferiority of SKP-021, a 0.3% ketoprofen patch, versus diclofenac sodium patch in patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains)

Studio clinico in doppio cieco, randomizzato, a gruppi paralleli, con farmaco di controllo, multicentrico per valutare la non-inferiorita' terapeutica del cerotto SKP-021 a base di ketoprofene 0,3% verso un cerotto a base di diclofenac-sodio in pazienti con condizione dolorosa ed infiammatoria (ad esempio: mal di schiena, livido, contusione, distorsione, stiramento)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical trial to evaluate if SKP-021, a 0.3% ketoprofen patch has an efficacy at least equal to diclofenac sodium patch in patients with back pain, bruise, contusion, sprain, strains

Studio clinico per valutare se il cerotto SKP-021 a base di ketoprofene 0,3% ha un'efficaccia almeno uguale a quella di un cerotto a base di diclofenac-sodio in pazienti con mal di schiena, livido, contusione, distorsione, stiramento.

A.4.1

Sponsor's protocol code number

SKP-021-01-11

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	PROMO INTERNATIONAL SRL
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	PROMO INTERNATIONAL SRL
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	SATO PHARMACEUTICAL LTD
B.4.2	Country	Japan
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GB PHARMA SERVICES
B.5.2	Functional name of contact point	RICERCA CLINICA
B.5.3	Address:
B.5.3.1	Street Address	FERRERI 11
B.5.3.2	Town/ city	PAVIA
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0382530676
B.5.5	Fax number	0382302619
B.5.6	E-mail	drotaru@gbpharmaservices.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	No
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.3.1	Product name	ketoprofen
D.3.2	Product code	SKP-021
D.3.4	Pharmaceutical form	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	KETOPROFEN
D.3.9.1	CAS number	22071-15-4
D.3.9.2	Current sponsor code	SKP-021
D.3.9.4	EV Substance Code	SUB08374MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	VOLTADOL*10CER MEDIC 140MG
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS CONSUMER HEALTH SpA
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	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DICLOFENAC SODIUM
D.3.9.1	CAS number	15307-79-6
D.3.9.4	EV Substance Code	SUB01674MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
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

patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains)

condizione dolorosa ed infiammatoria (ad esempio: mal di schiena, livido, contusione, distorsione, stiramento)

E.1.1.1

Medical condition in easily understood language

patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains)

condizione dolorosa ed infiammatoria (ad esempio: mal di schiena, livido, contusione, distorsione, stiramento)

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

E.2 Objective of the trial

E.2.1

Main objective of the trial

compare the efficacy of SKP-021 (medicated patch containing ketoprofen as an active ingredient) on pain in patients with traumatic disease versus Voltadol as standard treatment

comparare l'efficacia di SKP-021 (cerotto medicato contenente ketoprofene come principio attivo) versus Voltadol, nei pazienti con dolore di disturbi traumatici

E.2.2

Secondary objectives of the trial

evaluate the effect of treatments not only on pain, but also on mood and on daily activities and to evaluate the safety of the two treatments

valutare l'efficacia terapeutica non solo nel dolore,anche sull'umore e attività cotidiane e valutare la sicurezza di entrambe le terapie

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Out-patients of both sexes, aged between 18-65 years, able to give informed consent and to complete the diary will be included if have traumatic disease (e.g.: bruise, contusion, sprain, etc.), with presenting frank symptoms of inflammation, such as pain (VAS >50mm), myalgia and swelling, within 2 days of suffering trauma; if the patient has more than one affected site, one alone is to be treated, whichever severe.

Saranno arruolati pazienti ambulatoriali di entrambi i sessi, di età compresa tra 18-65 anni, in grado di dare un consenso informato e di completare il diario che presentino una malattia traumatica (ad esempio: livido, contusione, distorsione) con chiari sintomi di infiammazione, come dolore (VAS ≥ 50mm), mialgia e gonfiore, entro 2 giorni dal trauma; se il paziente ha più di un punto interessato, solo uno di questi sarà trattato, cioè quello più severo.

E.4

Principal exclusion criteria

Patients will be excluded mainly if: too wide the affected site, needing other anti-inflammatory analgesic than the study drug for the underlying disease, obese, with history of drug allergy or with aspirin asthma, with a skin wound or skin disease at the test site, pregnancy or lactating women.

I pazienti saranno esclusi dallo studio principalmente : se la zona interessata é troppo ampia , se necessitano di altri farmaci analgesici antinfiammatori rispetto al farmaco in studio, se sono obesi, se presentano storia di precedenti allergie ai farmaci o se soffrono di asma da aspirina, se hanno ferite cutanee o malattie cutanee nella zona da trattare, donne in gravidanza o allattamento.

E.5 End points

E.5.1

Primary end point(s)

Number of responders patients at the end of treatment period, i.e.: patients with reduced VAS score of at least 50% versus baseline condition.

Numero di responder all afine del trattamento: pazienti con un punteggio VAS ridotto del almeno del 50% rispetto alle condizioni iniziali.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the treatment period the proportions of responders (50% reduction at least of VAS score versus baseline condition) of the two groups will be compared by the chi square test.
The difference between treatment effects and its one-sided 97.5% confidence interval will be calculated and non-inferiority will be declared if the lower limit of the confidence interval will lie above -δ.

Al termine del periodo di trattamento le percentuali di responder (considerando almeno il 50% di riduzione del punteggio VAS rispetto alle condizioni iniziali) dei due gruppi verranno confrontate con il test del chi quadro.
Verrà calcolata la differenza tra gli effetti del trattamento ed il suo intervallo unilaterale di confidenza di 97,5% e la non-inferiorità sarà dichiarata se l'estremità inferiore dell'intervallo di confidenza sarà sopra -δ.

E.5.2

Secondary end point(s)

-Time needed to reach the status of responders
-Overall changes in VAS score
-Improvement of clinical symptoms related to the disease
-Changes in the MPAC scale with particular attention to mood profile
-Overall physician and patient rating on the treatment result

• Il tempo necessario per raggiungere lo status di responder
• I cambiamenti generali del punteggio VAS
• Il miglioramento dei sintomi clinici correlati alla malattia
• I cambiamenti nella scala MPAC con particolare attenzione al profilo umorale del paziente
• La valutazione generale del medico e del paziente sul risultato del trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

Time needed to reach the status of responder -the Kaplan-Meier curve and the curves of the two groups will be compared by the Log-rank test; Overall changes in VAS score. Improvement of clinical symptoms: difference in the improvement proportions of two groups will be analyzed by the logistic regression.
Changes in the MPAC scale: the three VAS scales will be evaluated for the overall changes in VAS score; for the 8 descriptors of pain and the overall ratings -Cochran-Mantel-Haenszel test. Vital Signs: the changes from baseline will be compared between groups by the ANCOVA. AEs: the incidence will be compared between groups by the chi square test or Fisher’s exact test

Il tempo per raggiungere lo stato di responder -curva di Kaplan-Meier e le 2 curve verranno confrontate con il Log-rank test. Cambiamenti generali nel punteggio VAS. Miglioramento dei sintomi clinici: la differenza nella proporzione di miglioramento dei due gruppi attraverso la regressione logistica. Cambiamenti nella scala MPAC: saranno valutate le tre scale -cambiamenti generali nel punteggio VAS; per gli otto descrittori e le valutazioni generali- Cochran-Mantel-Haenszel test. Segni Vitali: cambiamenti dall’ inizio tra i due gruppi paragonati con ANCOVA.EAs: l'incidenza sarà confrontata
tra i gruppi attraverso il test del chi quadro o il test esatto di Fisher

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

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:

680

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

700

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)

In case of study interruption or withdrawal from the study, the patient will receive anyway the therapeutical treatment and the best medical assistance requested for its clinical situation.

In caso di interruzione dello studio o di ritiro della partecipazione allo studio il paziente riceverà in ogni caso il trattamento terapeutico e la migliore assistenza medica necessari per la sua situazione clinica.

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

2012-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-16

P. End of Trial
P.	End of Trial Status	Completed

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