Clinical Trials Register

Summary
EudraCT Number:	2013-003418-42
Sponsor's Protocol Code Number:	WOE_2013_TUE
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:	2015-04-14
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

2013-003418-42

A.3

Full title of the trial

Effect of Mg-Orotate administration on cardiocirculatory Performance, the muscular concentration of phosphocreatine and the adaptation of muscle cellular level: A double blind, randomized, placebo-controlled, cross-over pilot study active ingredients versus placebo for 3 months

Einfluss einer Mg-Orotat-Gabe auf die kardiozirkulatorische Leistungsfähigkeit, die muskuläre Konzentration von Phosphokreatin und die Adaptation auf muskelzellulärer Ebene: Eine doppelverblindete, randomisierte, placebo-kontrollierte, cross-over Pilotstudie Verum versus Placebo über 3 Monate

A.3.1

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

Effect of the magnesium salt that combines the mode of action of magnesium and orotic acid (“vitamin B13”) on muscle fibers during training adaptations

A.4.1

Sponsor's protocol code number

WOE_2013_TUE

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	Wörwag Pharma 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	Wörwag Pharma 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	Wörwag Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	Sponser Medical Responsible Person
B.5.3	Address:
B.5.3.1	Street Address	Calwer Str. 7
B.5.3.2	Town/ city	Böblingen
B.5.3.3	Post code	71034
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4970316204411
B.5.5	Fax number	+4970316204419
B.5.6	E-mail	thomas.schuerholz@woerwagpharma.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	Yes
D.2.1.1.1	Trade name	Magnerot® CLASSIC N
D.2.1.1.2	Name of the Marketing Authorisation holder	Wörwag Pharma GmbH & Co. KG
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.3.1	Product name	Magnerot® CLASSIC N
D.3.4	Pharmaceutical form	Tablet
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	MAGNESIUM OROTATE-DIHYDRATE
D.3.9.3	Other descriptive name	MAGNESIUM OROTATE-DIHYDRATE
D.3.9.4	EV Substance Code	SUB117638
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	500
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)	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	Tablet
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

Evaluation of cardiocirculatory performance using clinical and relevant muscle laboratory parameters while taking Mg-Orotate and application of workouts

Beurteilung der kardiozirkulatorischen Leistungsfähigkeit anhand klinischer und muskelrelevanter Laborparameter unter der Einnahme von Mg-O und Anwendung von Trainingseinheiten

E.1.1.1

Medical condition in easily understood language

Evaluation of cardiocirculatory performance using clinical and relevant muscle laboratory parameters while taking Mg-Orotate and application of workouts

Beurteilung der kardiozirkulatorischen Leistungsfähigkeit anhand klinischer und muskelrelevanter Laborparameter unter der Einnahme von Mg-O und Anwendung von Trainingseinheiten

E.1.1.2

Therapeutic area

Health Care [N] - Environment and Public Health [N06]

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

In the proposed study the influence of a 4-week administration of MgOrotat (4500 mg / d) are examined for the training effect in healthy men. The effect of the medication is to be compared with the effect of (the standardized?) training. Finally, the interaction between workout and MgOrotat is examined, that is, whether the effect of MgOrotats and the training effect reinforce each other, inhibit or whether they act independently. To ensure the objectivity of performance or training success this are applied powerful physiological parameters of cardiopulmonary exercise testing and the lactate diagnostics. In addition, to be examined a potential effect of MgOrotat at the cellular level transfer based on muscle biopsies from the vastus muscle lateralis.

In der geplanten Studie soll der Einfluss einer 4 wöchigen MgOrotat-Gabe (4500 mg/d) auf den Trainingseffekt an gesunden Männern untersucht werden. Der Effekt der Medikation soll mit dem Effekt eines (des standardisierten?) Trainings verglichen werden. Schließlich wird die Wechselwirkung zwischen MgOrotat und Training untersucht, d.h. ob der Effekt des MgOrotats und der Trainingseffekt sich gegenseitig verstärken, hemmen oder ob sie unabhängig voneinander wirken. Zur Objektivierung der Leistungsfähigkeit bzw. des Trainingserfolges werden hierzu leistungsphysiologische Parameter aus der Spiroergometrie und der Laktatdiagnostik angewandt. Zusätzlich soll auf zellulärer Ebene anhand von Muskelbiopsien aus dem M. vastus lateralis ein potentieller Effekt der MgOrotat-Gabe untersucht werden.

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Potential volunteer are obliged to be informed in details about the study and the loading results. In the study only included, who afterword signs a dated consent form.
2. Men between 18 and 35 years, which may have a regular workout.
3. No serious internal medical or neurological pre-existing diseases in the history (as judged by the investigator).

1. Potentielle Probanden werden detailliert über die Studie und den daraus resultieren Belastungen und Pflichten informiert. In die Studie wird nur aufgenommen, wer danach eine Einverständniserklärung datiert unterschreibt.
2. Männer zwischen 18 und 35 Jahren, die ein regelmäßiges Training absolvieren können.
3. Keine schwerwiegenden internistischen oder neurologischen Vorerkrankungen in der Vorgeschichte (vom Investigator beurteilt).

E.4

Principal exclusion criteria

1. Chronic neurological or internal diseases.
2. Taking medications or food supplements and vitamins within the last 4 weeks.
3. Contraindications for the administration of magnesium orotate (e.g. allergy).
4. Contraindications for the application of local anesthetics (allergy, Hypersensitivity).
5. Participation in a drug trial within the last three months prior to study inclusion.
6. Clinically significant deviation of certain laboratory parameters (Hb <13 g / dl, Deviation of the liver values over twice the normal (ALT, AST, ALP), GFR <60 ml / min, serum electrolytes (Na, K, Mg) in the normal. PT / PTT value outside the normal.
7. Known coagulation disorders.
8. Taking drugs.
9. Venous conditions that do not allow multiple blood draws.

1. Chronische Erkrankungen aus dem neurologischen oder internistischen Bereich
2. Einnahme von Medikamenten oder Nahrungsergänzungsmitteln bzw. Vitaminen innerhalb der letzten 4 Wochen.
3. Kontraindikationen für die Gabe von Magnesiumorotat (z. B. Allergie).
4. Kontraindikationen für die Applikation von Lokalanästhetika (Allergie, Hypersensivitität).
5. Teilnahme an einer Medikamentenstudie innerhalb der letzten drei Monate vor Studieneinschluss.
6. Klinisch signifikante Abweichung der bestimmten Laborparameter (Hb < 13 g/dl, Abweichung der Leberwerte über das zweifache der Norm (GOT, GPT, GGT), GFR <60 ml/min, Serumelektrolyte (Na, K, Mg) nicht in der Norm. Quick/PTT Wert außerhalb der Norm.
7. Bekannte Gerinnungsstörungen.
8. Einnahme von Drogen.
9. Venenverhältnisse, die mehrfache Blutentnahmen nicht zulassen.

E.5 End points

E.5.1

Primary end point(s)

ΔVO2 max0-1: Change in VO2 max before and after training.
ΔP AT0-1: Change in performance on the cycle ergometer at the AT

ΔVO2 max0-1: Veränderung der VO2 max. vor Training und nach Training
ΔP AT0-1: Veränderung der Leistung auf dem Radergometer an der AT

E.5.1.1

Timepoint(s) of evaluation of this end point

before and after training

vor und nach dem Training

E.5.2

Secondary end point(s)

ΔLT0-1: Change in LT (lactate threshold) before training and after training
ΔPmax0-1: Changing the maximum performance on the cycle ergometer before training and after training
ΔKP0-1: Change in the concentration of creatine phosphate and ATP in the muscle before training and after training
ΔATP0-1: Change in the concentration of ATP (adenosine triphosphate) in the muscle before training and after training
ΔGly0-1: Change in the concentration of glycogen in the muscle before training and after Training

ΔLT0-1: Veränderung der LT vor Training und nach Training
ΔP max0-1: Veränderung der maximalen Leistung auf dem Radergometer vor Training und nach Training
ΔKP0-1: Veränderung der Konzentration von Kreatinphosphat und ATP im Muskel vor Training und nach Training
ΔATP0-1: Veränderung der Konzentration von ATP im Muskel
vor Training und nach Training
ΔGly0-1: Veränderung der Konzentration von Glykogen im Muskel vor Training und nach Training

E.5.2.1

Timepoint(s) of evaluation of this end point

before and after training

vor und nach dem Training

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

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

Yes

E.6.13.1

Other scope of the trial description

explorative pilot study

explorative Pilotstudie

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

Yes

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

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

last visit last patient

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)

F.2 Gender

F.2.1

Female

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

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)

None

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

2015-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-08-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-02-14

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