Clinical Trials Register

Summary
EudraCT Number:	2012-001420-35
Sponsor's Protocol Code Number:	LBP_Caps_v1
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:	2012-04-17
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

Austria - BASG

A.2

EudraCT number

2012-001420-35

A.3

Full title of the trial

The effect of a single skin treatment with Capsaicine 8% in low back pain

Der Effekt einer topischen Capsaicin 8% Behandlung bei chronischem Rückenschmerz im Lumbalbereich

A.3.1

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

Use of a Capsaicine 8% plaster for the treatment of low back pain

Studie zur Untersuchung der schmerzstillenden Wirkung eines Capsaicin Pflasters bei chronischen Kreuzschmerzen nach Durchführung einer Untersuchung mit quantitativsensorischer Testung

A.3.2

Name or abbreviated title of the trial where available

LBP_Caps

A.4.1

Sponsor's protocol code number

LBP_Caps_v1

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	Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien
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	Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien
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	Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien
B.5.2	Functional name of contact point	Abteilung für Anästhesie, Intensiv-
B.5.3	Address:
B.5.3.1	Street Address	Montleartstrasse 37
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1160
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431491504001
B.5.5	Fax number	+431491504009
B.5.6	E-mail	burkhard.gustorff@meduniwien.ac.at

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	Qutenza
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma Europe B.V.
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	Qutenza
D.3.4	Pharmaceutical form	Cutaneous patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	capsaicin
D.3.9.1	CAS number	404-86-4
D.3.9.3	Other descriptive name	CAPSAICIN
D.3.9.4	EV Substance Code	SUB13229MIG
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	179
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

chronic low back pain with neuropathic pain component or unclear neuropathic pain

chronischer Rückenschmerz im Lumbalbereich mit neuropathischer Schmerzkomponente

E.1.1.1

Medical condition in easily understood language

chronic low back pain

chronische Rückenschmerzen

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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

We want to demonstrate the efficacy of a single skin treatment with capsaicin 8% patch (Qutenza®) in patients suffering from low back pain with a neuropathic pain component according to the classification of symptoms with the Pain Detect questionnaire (scores > 18, neuropathic pain) compared to patients without a clear neuropathic pain component (scores ≤ 18 -13).

E.2.2

Secondary objectives of the trial

We further test the hypothesis, that the presence of heat hyperalgesia of the low back skin is a positive predictor of responsiveness.
We further test the hypothesis, that the presence of mechanical hyperalgesia of the low back skin is a positive predictor of responsiveness

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects are eligible for the study if all the following apply:
1. Men or women > 18 years.
2. Low back pain of all types with or without irradiation for 3 months or more.
3. Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10.
4. Pain Detect Score > 13.
5. No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day.
6. Intact skin surface at the potential patch application site.
7. Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination.
8. The participant has given written informed consent

E.4

Principal exclusion criteria

E.5 End points

E.5.1

Primary end point(s)

Mean change of pain intensity from baseline to 4 weeks after treatment on the NRS between the two treatment groups.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

E.5.2

Secondary end point(s)

1. Mean change of pain intensity from baseline after 1 week, 8 and 12 weeks on the NRS.
2. Responsiveness to treatment (more than 30% pain reduction at 4 weeks after treatment).
3. Percentage of responders of patients with and without heat hyperalgesia in the respective treatment group.
4. Percentage of responders of patients with and without mechanical hyperalgesia in the respective treatment group.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

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

E.6.5

Efficacy

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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.1.1.1

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

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.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)

not 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

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-02-02

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