Clinical Trials Register

Summary
EudraCT Number:	2011-000725-69
Sponsor's Protocol Code Number:	Z7202L03
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-06-07
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

Lithuania - SMCA

A.2

EudraCT number

2011-000725-69

A.3

Full title of the trial

Efficacy, tolerability and safety of Z7202, a once daily diclofenac diethylamine medicated plaster in the local treatment of painful conditions. Multi-centre, multinational, placebo- controlled, doubleblind, randomised, parallel-group study.

A.3.1

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

Efficacy, tolerability and safety of Z7202, a once daily diclofenac diethylamine medicated plaster in the local treatment of painful conditions.

A.4.1

Sponsor's protocol code number

Z7202L03

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	Zambon S.p.A.
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	Zambon S.p.A.
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	Zambon S.p.A
B.5.2	Functional name of contact point	Isabella Salerio
B.5.3	Address:
B.5.3.1	Street Address	Via Lillo del Duca 10
B.5.3.2	Town/ city	Bresso (MI)
B.5.3.3	Post code	20091
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0266524464
B.5.5	Fax number	+39 0266524648
B.5.6	E-mail	isabella.salerio@zambongroup.com

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	Diclofenac Diethylamine
D.3.2	Product code	Z7202
D.3.4	Pharmaceutical form	Medicated plaster
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 diethyl ammonium
D.3.9.1	CAS number	78213-16-8
D.3.9.2	Current sponsor code	Z7202
D.3.9.3	Other descriptive name	DICLOFENAC DIETHYLAMINE
D.3.9.4	EV Substance Code	SUB01669MIG
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	162.4
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Medicated plaster
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Localised painful conditions

E.1.1.1

Medical condition in easily understood language

Localised painful conditions

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLT
E.1.2	Classification code	10068757
E.1.2	Term	Musculoskeletal and connective tissue pain and discomfort
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

To assess the clinical efficacy of Z7202 diclofenac DEA medicated plaster (test), versus placebo on pain intensity on motion related to painful conditions (due to ankle sprains and/ or strains), detected by a 100 mm Visual Analogue Scale (VAS), on day 4

E.2.2

Secondary objectives of the trial

Secondary objectives of this study are to assess the clinical efficacy of Z7202 diclofenac DEA medicated plaster in terms of reduction of pain intensity at rest on day 4 and 8; reduction of pain intensity on motion on day 8; rescue medication consumption; global efficacy at the end of treatment; systemic safety and tolerability and local tolerability of Z7202 diclofenac DEA medicated plaster.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients, 18-70 years old
2. Patients with a diagnosis of single localized painful condition due to
ankle sprains and/ or strains: the time between injury/onset of pain and
treatment has to be less than 24 h, without any pre-treatment (with the
exception of local cold treatment)
3. Pain assessment: pain intensity on motion > 50 mm on the 100 mm
VAS
4. Full comprehension: ability to comprehend the full nature and purpose
of the study, including possible risks and side effects; ability to cooperate
with the investigator and to comply with the requirements of the
entire study
5. Informed Consent: signed written informed consent prior to inclusion
in the study.

E.4

Principal exclusion criteria

1. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study
2. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients including adhesives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study; in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) to aspirin or other non steroidal anti-inflammatory drugs (NSAIDs) and to acetaminophen
(paracetamol)
3. Diseases: any disease which in the investigator's judgement may interfere with the study evaluations or affect patient's safety; patients with neuropathic pain (e.g. neuropathic low back pain, post-herpetic nevralgia, diabetic neuropathy), osteoarthritis, fibromyalgia; tendonitis or tenosynovitis; history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); diagnosis including dementia, anxia, mental retardation; patients suffering from multiple sclerosis, Parkinson's Disease, Restless Legs Syndrome; significant kidney or liver disease; history of gastrointestinal ulcer or bleeding; blood coagulation disorders; rheumatic pain conditions; low back pain; known neoplastic diseases
4. Skin conditions: skin conditions affecting the site of application (i.e. wound, eczema, weeping dermatitis); open lesions
5. Serious injuries, including a fracture, nerve injury and a tear of ligament, muscle or cartilage
6. Medications: use of paracetamol within 24 h before the inclusion; use of aspirin or NSAIDs within 36 h before the inclusion; use of topical preparations applied to the painful region within 7 days before the inclusion, including herbal products; use of opioids within 7 days before the inclusion; systemic and dermatological preparations of corticosteroids within 30 days before the inclusion; use of myorelaxant drugs within 24 h before the inclusion; use of any physical therapy (physiotherapy and kinesis-therapy) apart from
local cold application within 48 h before the inclusion
7. Clinical trials: participation in the evaluation of any drug within 3 months prior to the start of the study
8. Drug, alcohol: history of drug or alcohol abuse
9. Pregnancy:
- pregnant or lactating women;
- women of childbearing potential if not using a reliable method of contraception;
- women of not child-bearing potential unless permanently sterilised or in postmenopausal status for at least 2 years.

E.5 End points

E.5.1

Primary end point(s)

To compare the diclofenac DEA medicated plaster versus Placebo in terms of change in pain intensity on motion from baseline to day 4, evaluated using a 100 mm VAS.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 4

E.5.2

Secondary end point(s)

Secondary end-points are the comparison between treatments in terms of:
- change in pain intensity at rest from baseline to Day 4 and Day 8, a 100
mm VAS
- change in pain intensity on motion from baseline to Day 8, evaluated
using a 100 mm VAS;
- proportion of patients achieving at least 50% pain relief on motion by
Day 4, (i.e. responders);
- proportion of patients achieving 20, 50 and 70% pain relief on motion,
at any point during the study;
- time to 50% pain relief on motion;
- time to first rescue medication, proportion of patients using rescue
medication and amount of rescue medication from randomization until
day 4 and at the end of treatment;
- proportion of patients withdrawing due to treatment failure and time to
withdrawal due to treatment failure;
- global efficacy evaluation by both investigator and patient at the end of
the treatment (day 8);
- systemic safety and tolerability assessed by both investigator and
patient;
- local tolerability assessed every day by patient (erythema, itching and
burning) during the treatment and investigator (erythema) on days 8
and 15;
- incidence of adverse events and vital signs evaluations.

E.5.2.1

Timepoint(s) of evaluation of this end point

Days 4, 8 or 15

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)

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Last subject last visit

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:

170

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

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

176

F.4.2.2

In the whole clinical trial

176

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)

Participants will be treated in accordance with normal standard of care by their usual physician.

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

2011-11-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-07

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