Clinical Trials Register

Summary
EudraCT Number:	2011-004089-13
Sponsor's Protocol Code Number:	KLF/K/019811
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:	2011-11-29
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

2011-004089-13

A.3

Full title of the trial

Placebo-controlled exploratory pilot study to investigate the effect and onset of action of Traumaplant® for delayed onset muscle soreness.

Placebo-kontrollierte, explorative Pilotstudie zur Untersuchung der Wirkung und des Wirkungseintritts von Traumaplant® bei belastungsinduzierten Mikrotraumata des Skelettmuskels (DOMS; delayed onset muscle soreness)

A.3.1

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

A placebo-controlled clinical study to investigate the effect and onset of action of Traumaplant® for the treatment of muscle soreness

Placebo-kontrollierte explorative Pilotstudie zur Untersuchung der Wirkung und des Eintritts der Wirkung von Traumaplant® bei Muskelkater

A.4.1

Sponsor's protocol code number

KLF/K/019811

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	Cassella-med GmbH & Co. KG
B.1.3.4	Country	Germany
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	Cassella-med GmbH & Co. KG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Cassella-med GmbH & Co. KG
B.5.2	Functional name of contact point	Medical Science Division
B.5.3	Address:
B.5.3.1	Street Address	Motzener Straße 41
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	12277
B.5.3.4	Country	Germany
B.5.4	Telephone number	4902211652750
B.5.5	Fax number	4902211652376
B.5.6	E-mail	mwze@cassella-med.de

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	Traumaplant
D.2.1.1.2	Name of the Marketing Authorisation holder	Harras Pharma Curarina GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Cream
D.3.4.1	Specific paediatric formulation	No
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	Symphytum x uplandicum NYMAN
D.3.9.1	CAS number	8000040-21-3
D.3.9.3	Other descriptive name	SYMPHYTUM OFFICINALE
D.3.9.4	EV Substance Code	SUB15446MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Cream
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

delayed onset muscle soreness (DOMS)

belastungsinduzierte Mikrotraumata des Skelettmuskels

E.1.1.1

Medical condition in easily understood language

muscle soreness

Muskelkater

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	LLT
E.1.2	Classification code	10028332
E.1.2	Term	Muscle soreness
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

Assess the difference between one-time topical application of verum and placebo regarding the effect and the onset of action in treating DOMS of the biceps brachii muscle.Variable for it is the change of PPT, measured before and after the muscular exercise of the upper arm musculature (v1 and v2) as well as several times within 4 hours after application of verum and placebo (visit2) determined by using an electronic pressure algometer.Further the movement pain in the upper arms of the subjects (VAS) to the times indicated above as well as the pain-free mobility in the elbow joints are determined and evaluated in the group comparison. Global evaluation of the clinical effect and tolerability as well as the occurrence of adverse events are documented and evaluated. The exploratory approach is chosen because there are no previously literature data concerning the effect of the investigational product in DOMS. It is an initial collection of basic data for the generation of specific issues.

Unterschied zwischen der Anwendung von Verum und Placebo hinsichtlich der Wirkung und des Wirkungseintritts bei DOMS. Zielvariable ist die Änderung der Druckschmerzschwelle (PPT). Diese wird vor und nach der muskulären Belastung der Oberarmmuskulatur (V1 und V2) sowie mehrmals innerhalb von 4h nach Anwendung des Prüfpräparats bzw. Placebos (V2) durch algometrische Messungen ermittelt. Weiterhin werden die Bewegungsschmerzen in den Oberarmen mittels VAS zu den oben angegebenen Zeitpunkten sowie die schmerzfreie Beweglichkeit in den Ellbogengelenken ermittelt und im Gruppenvergleich ausgewertet. Dokumentation und Auswertung der globalen Beurteilung der Wirkung und Verträglichkeit; Auftreten unerwünschter Ereignisse.
Der explorative Ansatz zur Auswertung dieser Pilotstudie wird gewählt, da bislang keine literaturbekannten Daten zur Wirkung des Prüfpräparats bei DOMS vorliegen, so dass erstmalig Basisdaten für die Generierung spezifischer Fragestellungen zu erheben sind.

E.2.2

Secondary objectives of the trial

all objectives are main objectives

alle Zielvariablen sind Hauptzielvariablen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- male and female subjects, aged 18-45 years
- written informed consent of the subjects
- sufficiently physical capacity
- muscle pain (DOMS) in biceps brachii muscles (bilateral) after exercise within 48 hours
- body mass index of less than or equal 30

- Alter 18 bis 45 Jahre
- ausreichende körperliche Belastbarkeit
- unterschriebene Einwilligungserklärung
- Muskelschmerzen im M. biceps brachii (beidseits) nach muskulärer Belastung innerhalb 48h
- BMI ≤ 30

E.4

Principal exclusion criteria

- disorders or injuries of the skeletal musculature and the connective and supporting tissue (arms, shoulder belt, back)
- neurological disorders
- skin diseases (e.g. neurodermitis, psoriasis)
- arterial hypertension
- any diseases or conditions, that affect adversely the risk-benefit ratio from investigator´s point of view or affect the study conduct (e.g. cardiovascular diseases, diseases of the lung, skin diseases)
- regular training of arm and shoulder muscles
- topical application and/or oral administration of pain-relieving medications (for a period of 2 days before visit 1 and during the trial)
- any local therapy in the entire upper body area, e.g. thermotherapy or massage during the trial
- known sensitivity to the ingredients of the IMP
- Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method
- any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking)
- simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial

- Erkrankungen oder Verletzungen der Skelettmuskulatur und des Binde- und Stützgewebes (Arme, Schultergürtel, Rücken)
- neurologische Erkrankungen
- Hauterkrankungen (z.B. Neurodermitis, Psoriasis usw.)
- arterielle Hypertonie
- jegliche Erkrankungen oder Zustände, die aus Sicht der Prüferin das Nutzen-Risiko-Verhältnis für den Teilnehmer ungünstig beeinflussen oder die Durchführung der Studie beeinträchtigen (z.B. Herz-Kreislauf-, Lungen- oder Hauterkrankungen)
- regelmäßiges Training der Arm- und Schultergürtelmuskulatur
- topische Anwendung und/oder orale Einnahme von schmerzstillenden Präparaten (Karenzzeit: 2 Tage vor Visite 1 und während der Prüfung)
- jegliche lokale Therapie im Oberkörperbereich wie bspw. Wärmebehandlung oder Massage während der Prüfungsdauer
- bekannte Allergien gegen Bestandteile des Prüfpräparats
- Schwangerschaft/Stillzeit
- Medikamenten-, Alkohol- und/oder Drogenabusus
- gleichzeitige Teilnahme an einer anderen klinischen Prüfung oder Teilnahme an einer solchen innerhalb der letzten 6 Wochen

E.5 End points

E.5.1

Primary end point(s)

comparison of verum and placebo: change (baseline vs. end of trial) in pressure pain threshold, movement pain in the upper arms of the subjects (VAS) and pain-free mobility in the elbow joints

Gruppenvergleich Verum/Placebo: Veränderungen in der Druckschmerzschwelle (PPT), dem Bewegungsschmerz im Oberarm der Probanden mittels VAS und in der schmerzfreien Beweglichkeit im Ellbogengelenk (mittels Winkelmesser)

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline after the muscular exercise of the upper arm musculature (visit 2) and during 4 hours after application of verum and placebo (visit 2)

Baseline nach der muskulären Belastung der Oberarmmuskulatur (Visite 2) sowie mehrmals innerhalb von 4 Stunden nach Anwendung des Prüfpräparats bzw. Placebos (Visite 2)

E.5.2

Secondary end point(s)

All end points are primary end points

Alle Endpunkte sind primäre Endpunkte

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable

nicht anwendbar

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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 zuletzt eingeschlossenen Probanden

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.1.1.1

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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)

Following the end of participation (after visit 2) we recommends to the subjects to avoid high force loads of their upper arms and accomplish light extension exercises. DOMS does not leave permanent damage in the musculature involved and after at the latest one week will fade away. If the test person should feel strong pain, one recommends to it to contact the investigator or its family doctor.

Im Anschluss an die Prüfung (nach Visite 2) wird den Probanden empfohlen, hohe Kraftbelastungen Ihrer Oberarme zu vermeiden und leichte Dehnübungen durchzuführen. Ein Muskelkater hinterlässt keine bleibenden Schäden in der beteiligten Muskulatur und wird nach spätestens einer Woche abklingen. Sollte der Proband starke Schmerzen verspüren, wird ihm empfohlen, den Prüfer oder seinen Hausarzt zu kontaktieren.

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

2011-12-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-12-20

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