Clinical Trials Register

Summary
EudraCT Number:	2013-001221-13
Sponsor's Protocol Code Number:	2639063
National Competent Authority:	Norway - NOMA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-07-30
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

Norway - NOMA

A.2

EudraCT number

2013-001221-13

A.3

Full title of the trial

Dupytren’s disease study
A randomized controlled trial comparing clostridium histolyticum with needle aponeurotomy.

A.3.1

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

Dupytren’s disease study
A randomized controlled study comparing enzyme treatment (with clostridium histolyticum) with needle transection of Dupytren’s finger contracture.

A.4.1

Sponsor's protocol code number

2639063

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	Akershus university hospital
B.1.3.4	Country	Norway
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	Interne forskningmidler Akershus universitetssykehus
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Akershus universitetssykehus
B.5.2	Functional name of contact point	Ortopedisk avdeling
B.5.3	Address:
B.5.3.1	Street Address	Sykehusveien 25
B.5.3.2	Town/ city	Lorenskog
B.5.3.3	Post code	1478
B.5.3.4	Country	Norway
B.5.4	Telephone number	4702900
B.5.5	Fax number	4767968861
B.5.6	E-mail	postmottak@ahus.no

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	Clostridium Histolyticum (Xiapex)
D.2.1.1.2	Name of the Marketing Authorisation holder	Auxillium
D.2.1.2	Country which granted the Marketing Authorisation	Norway
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	Xiapex
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous 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)	Yes
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

Dupytren’s disease, primary MCP joint contractures of the third, forth and fifth finger of the hand.

E.1.1.1

Medical condition in easily understood language

Dupytren’s disease of the basal joint of the third, fourth or the fifth finger of the hand. Patient that have not been treated before with any other treatment.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

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	10009904
E.1.2	Term	Collagen disorder NOS
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

A prospective randomized open label trial comparing the treatment results following injections of Clostridium Histolyticum with that of needle aponeurotomy for patients that have not been treated on the involved hand. With focus on the functional results and risks for complications and recurrence of the contracture.

E.2.2

Secondary objectives of the trial

Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint.
In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

We will also conduct a treatment-cost analysis. By recording the cost of each treatment, need of sick leaves, cost of additional doctor’s appointments and repeated surgery due to recurrence or complications, we will be able to evaluate the cost effectiveness and not only the functional results. This provides the necessary economic frame of reference from which to resolve treatment recommendations

E.3

Principal inclusion criteria

• 30 ° or more contracture of one MCP-joint (3. -5. Finger)
• Less than 20 ° contracture of adjacent PIP joint
• Single hand involvement
• Primary contracture (not operated or treated hand earlier for this condition)
• Patients 18 years or older.

E.4

Principal exclusion criteria

• Patients with under 30 ° MCP joint contracture or
• 20 ° or more contracture of the adjacent PIP
• Ongoing treatment with platelet inhibitors
• Prior treatment with tetracycline, 2 weeks earlier to treatment
• Patients who are pregnant
• Patients with known allergic reaction to local anesthetic or Clostridium Histolyticum
• Patients that have been treated for Dupuytren´s earlier on involved hand
• Involvement with “need to treat” of both hands

E.5 End points

E.5.1

Primary end point(s)

Correction of the contracture in degrees constitutes the primary endpoint and will be measured by a manual finger goniometer at follow-up

E.5.1.1

Timepoint(s) of evaluation of this end point

1,4 week and 1,2 and 5 years

E.5.2

Secondary end point(s)

Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer

E.5.2.1

Timepoint(s) of evaluation of this end point

1,4 week and 1,2 and 5 years

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

aponeurotomy

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

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)

If a patient develops a need to treat the same finger or others of the same hand (secondary end point) during the follow-up, the patient will receive appropriate treatment and exit the study protocol.

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

2013-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-06

P. End of Trial
P.	End of Trial Status	Ongoing

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