Clinical Trials Register

Summary
EudraCT Number:	2012-004403-13
Sponsor's Protocol Code Number:	PDT002/12
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-08
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

Austria - BASG

A.2

EudraCT number

2012-004403-13

A.3

Full title of the trial

Placebo-controlled cross-over study on the efficacy of a non-steroidal antirheumatic drug for pain reduction during photodynamic therapy of actinic keratoses

Placebo-kontrollierte Cross-over Studie über die Wirksamkeit eines nichtsteroidalen Antirheumatikums zur Schmerzlinderung bei der photodynamischen Therapie von aktinischen Keratosen

A.3.1

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

Evaluation of diclofenac for pain reduction during photodynamic therapy

Beurteilung von Diclofenac zur Schmerzreduktion während der Photodynamischen Therapie

A.4.1

Sponsor's protocol code number

PDT002/12

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	Medizinische Universität Wien, Univ. Klinik für Dermatologie
B.1.3.4	Country	Austria
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	Dept of Dermatology
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Division of General Dermatology
B.5.2	Functional name of contact point	Secretariat
B.5.3	Address:
B.5.3.1	Street Address	Waehringer Guertel 18-20
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	00431404007702

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	Voltaren 50 mg rapid
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma GmbH, Wien
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Voltaren 50 mg rapid
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	diclofenac potassium
D.3.9.1	CAS number	15307-81-0
D.3.9.3	Other descriptive name	Diclofenac potassium
D.3.9.4	EV Substance Code	SUB13568MIG
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	50
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	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

actinic keratosis

aktinische Keratosen

E.1.1.1

Medical condition in easily understood language

superficial skin cancer

oberflächlichler Hautkrebs

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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

To evaluate the influence of a single dose of diclofenac on pain development during photodynamic therapy

Den Einfluss von Einmaldosis von Diclofenac auf die Schmerzentwicklung während der PDT zu evaluieren

E.2.2

Secondary objectives of the trial

to evaluate whether the methods used for pain reduction have an impact on the severity of the local skin reaction or the long-term response rates. in addition, to evaluate the cosmetic outcome and the patients`global satisfaction with the treatment

zu evaluieren, ob sich die Interventionen zur Schmerzreduktion hinsichtlich der Intensität der phototoxischen Hautreaktion und der Abheilungsraten der Läsionen unterscheiden. Weitere sekundäre Zielparameter sind das kosmetische Ergebnis und die globale Patientenzufriedenheit.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

patients with actinic keratoses on the head; age 18 years or older

Patienten mit aktinischen Keratosen im Kopfbereich; Alter gleich oder größer 18 Jahre

E.4

Principal exclusion criteria

intolerance to topically applied aminolevulinic acid; intolerance or allergy to diclofenac; florid and untreated gastric or duodenal ulcer

Intoleranz von topisch applizierter Aminolävulinsäure; Intoleranz oder Allergie von/auf Diclofenac; unbehandeltes oder florides Magen- oder Zwölffingerdarmgeschwür

E.5 End points

E.5.1

Primary end point(s)

median pain score during and after PDT treatment

Medianer Schmerzwert während und nach der PDT

E.5.1.1

Timepoint(s) of evaluation of this end point

1, 5, 9, 13 and 17 minutes after initiation of PDT and 10, 20 ad 30 minutes after end of treatment

1, 5, 9, 13 und 17 min nach Beginn der Bestrahlung sowie 10, 20 und 30 Minuten nach Beendigung der Therapie

E.5.2

Secondary end point(s)

- the intensity of the local skin reaction
- the rate of complete response
- rhe cosmetic outcome
- patients` global satisfaction with the treatment

- die Intensität der lokalen Hautreaktion
- die Abheilungsrate
- das kosmetische Ergebnis
- die Beurteilung der globalen Patientenzufriedenheit

E.5.2.1

Timepoint(s) of evaluation of this end point

- immediately, 30 min, 2 and 7 days after PDT
- 3, 6 and 12 months after PDT
- 12 months after PDT
- 12 months after PDT

- unmittelbar, 30 min sowie und 2 und 7 Tage nach der PDT;
- 3, 6 Monate und 12 Monate nach der PDT;
- nach 12 Monaten
- nach 12 Monaten

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

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

Yes

E.8.2.3.1

Comparator description

Voltaren 50mg rapid

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.8.5

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

Letzte Visite des letzten Patienten

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.1.1.1

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

F.3.3.1

Women of childbearing potential not using contraception

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

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)

patients will be followed in our PDT outpatient clinic

die Patienten werden in unserer PDT Ambulanz nachbetreut

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

2013-08-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-06-15

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