Clinical Trials Register

Summary
EudraCT Number:	2016-004792-50
Sponsor's Protocol Code Number:	C1502
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:	2017-06-07
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

2016-004792-50

A.3

Full title of the trial

Multi-centre, Double-blind, Randomised, Active- and Placebo-Controlled, Confirmatory Trial to Demonstrate Efficacy and Safety of Traumed® Gel in Patients having Acute Ankle Sprain

A.3.1

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

Traumed - a study that evaluates the efficacy and safety of Traumed® gel in patients with acute ankle sprain

A.3.2

Name or abbreviated title of the trial where available

Traumed Trial

A.4.1

Sponsor's protocol code number

C1502

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	Biologische Heilmittel Heel GmbH
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	Biologische Heilmittel Heel GmbH
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	Biologische Heilmittel Heel GmbH
B.5.2	Functional name of contact point	Dr. Christine Frank
B.5.3	Address:
B.5.3.1	Street Address	Dr.-Reckeweg-Straße 2-4
B.5.3.2	Town/ city	Baden-Baden
B.5.3.3	Post code	76532
B.5.3.4	Country	Germany
B.5.4	Telephone number	004972215013188
B.5.5	Fax number	00497221501650
B.5.6	E-mail	christine.frank@heel.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	Traumeel® Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	Biologische Heilmittel Heel GmbH
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.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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	Yes
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Diclofenac Heumann Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	HEUMANN PHARMA GmbH & Co. Generica 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.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DICLOFENAC SODIUM
D.3.9.3	Other descriptive name	DICLOFENAC SODIUM
D.3.9.4	EV Substance Code	SUB01674MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Gel
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute Ankle Sprain

Verstauchung des Sprunggelenks

E.1.1.1

Medical condition in easily understood language

Ankle Sprain

Verstauchung des Sprunggelenks

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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 study is to demonstrate the superior efficacy of Traumed® gel versus placebo in patients with acute lateral ankle sprain

E.2.2

Secondary objectives of the trial

The secondary objectives are:
• to assess non-inferiority of Traumed® gel compared to diclofenac gel
• to assess the tolerability and safety of Traumed® gel.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Acute unilateral Grade 1 or Grade 2 sprain of the lateral ankle
2. ≥ 18 years of age
3. Legally competent male or female outpatient
4. Injury occurred within previous 24 hours before first treatment expected
5. Signed Informed Consent
6. After 5 minutes of rest, pain on passive movement by investigator measured by Visual Analog Scale (VAS)>50 mm
7. Not pregnant (as proven by negative pregnancy test in case of women of childbearing potential before first study drug administration) or breast-feeding. Females of childbearing potential must agree to maintain highly effective birth control throughout the study (see all details in section 9.6). Such methods include:
• oral, intravaginal, transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation,
• oral, injectable, implantable hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (if received medical assessment of the surgical success), sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of trial participation).

E.4

Principal exclusion criteria

1. Similar injury affecting the same joint within the past 6 months
2. Bilateral ankle injury
3. Grade 3 ankle sprain
4. Fracture of the ankle (It should be excluded by using e.g. the Ottawa Ankle Rules. In case of any doubt the exclusion of fracture by x-ray should be considered as per standard of care)
5. Chronic joint disorders such as clinically relevant osteoarthritis or aseptic arthritis
6. Disorders that may lead to joint oedema for other reasons than ankle sprain (such as heart failure, thrombosis, lymphedema and others)
7. Diagnosis requiring bed rest, hospitalization, surgery, or use of any cast during the planned treatment period
8. Debilitating acute or chronic illness
9. Use of systemic and/or topical corticosteroids in the previous 8 weeks, any analgesics (e.g. paracetamol/ acetaminophen) in the previous 24 hours before Screening Visit, or 48 hours in the case of long-acting non-steroidal anti-inflammatory drug (NSAID), cyclooxygenase type 2 (COX-2) specific inhibitors, or tramadol and other opioids. Low dose acetylsalicylic acid (70 – 100 mg per day) for anti-thrombotic therapy is permitted if doses are stable for the month prior to Screening Visit and planned to be stable during the entire study
10. History of sensitivity to any component of the study drugs (including e.g. paracetamol/ acetaminophen intolerance; patients in whom asthma attacks, skin rash or acute rhinitis are triggered by acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs)
11. Unwilling or unable to comply with all the requirements of the study protocol
12. Concurrent injury to proximal structures in ipsilateral lower extremity (i.e. concurrent shin, knee, thigh, or hip injury)
13. History of ligament avulsion, fracture or surgery to the affected lower extremity
14. Presence of infections and/or skin diseases in the area of the study treatment site (including psoriasis)
15. Any previous treatments of the injured ankle, whether topical or systematic, are prohibited except RICE (simultaneous combination of all 4 elements Rest, Ice, Compression and Elevation which is restricted to be used until starting treatment with the investigational drug).
16. Participation in any clinical study within the past 4 weeks
17. Any relationship of dependence with the sponsor or with the investigator

E.5 End points

E.5.1

Primary end point(s)

Area under the curve (AUC)* for pain on passive movement in Visual Analog Scale (VAS) from baseline to Day 4

*All AUC calculations will be based on actual time of measurement

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 4

E.5.2

Secondary end point(s)

Secondary Efficacy Variables

• AUC for pain at rest in VAS from baseline to Day 4
• AUC for pain on passive movement in VAS from baseline to Day 2, 7 and Final Visit
• AUC for pain at rest in VAS from baseline to Day 2, 7 and Final Visit
• Change from baseline of pain on passive movement in VAS to Day 4, 7 and Final Visit
• Change from baseline of pain at rest in VAS to Day 4, 7 and Final Visit
• Change from baseline to Day 2, 4, 7 and Final Visit in the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale
• Amount of rescue medication (doses)
• Time to 50% improvement of pain at rest measured by VAS

Safety Variables
• Adverse Events (AEs)
• Other observations related to safety (physical examinations and vital signs).

E.5.2.1

Timepoint(s) of evaluation of this end point

• Day 4
• Day 2, 7 and Final Visit, which is Day 14
• Day 2, 7 and Final Visit, which is Day 14
• Day 4, 7 and Final Visit, which is Day 14
• Day 4, 7 and Final Visit, which is Day 14
• Day 2, 4, 7 and Final Visit, which is Day 14
• whole study duration
• tbd

Safety Variables
• whole study duration
• whole study duration

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)

Yes

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

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

End of trial is defined as completion of the data base lock.

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:

750

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

808

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)

The patients will be treated according to the local medical practice.

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

2017-08-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-08-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-03-25

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