Clinical Trials Register

Summary
EudraCT Number:	2010-020489-82
Sponsor's Protocol Code Number:	Q16-10-01
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-06-09
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

Germany - BfArM

A.2

EudraCT number

2010-020489-82

A.3

Full title of the trial

Randomised, double-blind, placebo-controlled, parallel-groups, multi-centre clinical trial Phase III with Diclofenac Sodium 140 mg medicated plaster in patients with fresh impact injuries of the limbs.

A.3.2

Name or abbreviated title of the trial where available

Diclofenac Sodium 140 mg medicated plaster with fresh impact injuries of the limbs

A.4.1

Sponsor's protocol code number

Q16-10-01

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fidia Farmaceutici 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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 Sodium 140 mg Medicated Plaster
D.3.2	Product code	not applicable
D.3.4	Pharmaceutical form	Medicated plaster
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
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.3.9.2	Current sponsor code	Diclofenac Sodium medicated plaster
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Fresh impact injuries of the limbs (Contusions, strains and sprains)

MedDRA Classification

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 primary objective of the trial is to show superior efficacy of Diclofenac Sodium 140 mg medicated plaster over Placebo plaster as assessed by absolute change of pain on movement from baseline Visit 1 (Day 1) to Visit 3 (Day 3) in the indication fresh impact injuries of the limbs.

E.2.2

Secondary objectives of the trial

The secondary objectives of the clinical trial are the evaluation of the trial drug's efficacy with reagrd to secondary efficacy variables and safety in comparison to Placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males or females, age range 18-60 years, outpatients.
2. Good general health.
3. Written informed consent.
4. Fresh impact injury of the limbs presented within 3 hours after injury.
5. The size of the visible traumatisation must be at least 25 cm2 and maximal 150 cm2 (in case of a muscle strain the area is assessed through palpation).
6. Pain assessment on movement by patient greater or equal 40 mm at baseline Visit 1 on a 100 mm VAS.

E.4

Principal exclusion criteria

1. History of blood coagulation disorders.
2. History of asthma, COPD, hay fever and swelling of nasal mucosa.
3. Pregnancy or lactation period.
4. Women with childbearing potential without effective contraceptive methods.
5. Known allergy or hypersensitivity to: Diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAIDs or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients of the plaster, such as butylated methacrylate copolymer, copolymer acrylate vinyl acetate, PEG 12 stearate, sorbitan oleate.
6. Current skin disorders/open wounds in the area to be treated.
7. Gastric and intestinal ulcer.
8. Gastrointestinal, cerebrovascular or other active bleedings.
9. Evidence of liver, kidney or haematopoetic disorders.
10. Patients affected by rheumatoid arthritis or gout.
11. Known malignant diseases in the last 5 years.
12. Pre-treatment of injury. Previous cooling (ice, cooling spray) is authorised prior to screening . It is also allowed to cool the injury during the screening period until randomisation with a moist cloth and water at room temperature (no ice, no cooling spay).
13. Any patient, in the investigators opinion not considered suitable for enrolment.
14. Anticipated poor compliance by the patient.
15. Use of non-steroidal anti-inflammatory drugs, analgesics (e.g. acetyl salicylic acid, with the exception of paracetamol) or psychotropic agents within 3 days before trial participation or corticosteroids oral within 2 weeks or intravenous within 4 weeks before trial participation.
16. Use of glucosamine, chondroitine sulphate, diacerine, hyaluronic acids and bisposphonates in the last 4 weeks.
17. Participation in another clinical trial and/or treatment with an experimental drug within 4 weeks before participation in the trial.
18. Previous participation in this clinical trial.
19. Any relevant surgical treatment during the previous 2 months or planned during the trial.
20. Patient with a history of serious psychiatric disorders.
21. Abuse of alcohol, medicaments or illicit drugs.

E.5 End points

E.5.1

Primary end point(s)

Absolute change in pain on movement from baseline Visit 1 (Day 1) to Visit 3 (Day 3) (whil moving the arm or walking 5 steps on an even surface) assesed by patient on Visual Analogue Scale (VAS)

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.8.3

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

Information not present in EudraCT

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

see protocol

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	190

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

2010-08-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-08-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-04-14

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