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    The EU Clinical Trials Register currently displays   35898   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004251-76
    Sponsor's Protocol Code Number:87230
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-30
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-004251-76
    A.3Full title of the trial
    A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren’s Contracture in adult patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is collagenase injection as effective as surgery for the treatment of moderate Dupuytren’s Contracture in adult patients?
    A.3.2Name or abbreviated title of the trial where available
    Dupuytren’s Interventions Surgery vs. Collagenase (DISC)
    A.4.1Sponsor's protocol code number87230
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospitals of Leicester NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of York
    B.5.2Functional name of contact pointYork Trials Unit,
    B.5.3 Address:
    B.5.3.1Street AddressLower Ground Floor ARRC Building, Department of Health Science
    B.5.3.2Town/ cityYork
    B.5.3.3Post codeYO10 5DD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01904321116
    B.5.6E-mailcatherine.arundel@york.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xiapex
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrium AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXiapex
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCollagenase Clostridium Histolyticum
    D.3.9.1CAS number 9001-12-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dupuytren's contracture
    E.1.1.1Medical condition in easily understood language
    Dupuytren’s Contracture is a common problem of the hand caused by fibrous tissue build up, which forces the finger to bend down into the palm leading to an inability to straighten the finger.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10013872
    E.1.2Term Dupuytren's contracture
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10013873
    E.1.2Term Dupuytren's contracture operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether collagenase injection is as good as surgery (limited fasciectomy) in the correction of Dupuytren’s contracture of the hand
    E.2.2Secondary objectives of the trial
    To investigate the cost-effectiveness of collagenase injections compared to surgery (limited fasciectomy) 2 years after treatment.

    To investigate whether the correction achieved after collagenase injection or surgery is maintained to 5 years (If justified by findings from the analysis at 1 year and 2 years)

    To explore patient’s experiences and preferences of the different treatments (Qualitative sub study).

    To investigate if remote measurement (using photographs) of finger extension is as good as goniometric measurements in clinic to determine recurrence (Photography sub study).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Qualitative sub-study:
    If a patient agrees to take part in the qualitative sub-study they may be asked to participate in a semi-structured interview to generate information on benefits and difficulties associated with each treatment.

    2. Photography sub-study:
    If a patient agrees to take part in the photography sub-study, they will be asked to take photographs of their hand at baseline, 3 months and 6 months and to send these to the study team. Patients will be provided with instructions on how to complete the photographs
    E.3Principal inclusion criteria
    • Male or Female and aged 18 years or over
    • Presence of discrete, palpable, contracted cord involving the metacarpophalangeal joint and/or proximal interphalangeal joint of a finger
    • Degree of contracture >30 degrees in either joint i.e. patient cannot put the palm of the hand flat on a table (Hueston’s Tabletop test)
    • Able to identify a predominant finger for treatment which would not require more than one collagenase injection as treatment for a single cord
    • Appropriate for limited fasciectomy and collagenase injection for Dupuytren’s contracture (i.e. not requiring skin grafting or PNF (eg discrete MCP cords in elderly))
    • Patient is willing and able to give informed consent for participation in the study.

    E.4Principal exclusion criteria
    • Severe contractures of both metacarpophalangeal joint and/or proximal interphalangeal joints (Tubiana Grade 4)
    • History of previous intervention for Dupuytren’s contracture (e.g. limited fasciectomy, collagenase injection or needle fasciectomy) on the same hand
    • History of any other pre-existing disorder of the hand causing restriction of movement and/or pain and affecting hand function e.g. post traumatic stiffness, stiffness due to other causes, infection, arthritis
    • Non-English speaking because of the need to complete multiple questionnaires which have not been validated in multiple languages
    • Resident in a location where attendance for follow up at one of the study recruiting centres will not be possible
    • Contraindicated for use of Collagenase
    • Any other significant disease or disorder (including autoimmune disorders) which, in the opinion of the Investigator, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    • Participants who have participated in another research study involving an investigational product in the past 12 weeks
    • Female participants who are pregnant or breastfeeding

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in Patient Evaluation Measure (PEM) between baseline and 1 year. PEM is a validated patient report questionnaire of 11 items in the Hand Health and three in the Overall Assessment Questionnaire (including a transition question).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered
    E.5.2Secondary end point(s)
    - Unité Patient Rated Outcome Measure (URAM): A validated, nine item, six interval disease specific disability scale.
    - Michigan Hand Questionnaire (MHQ): A validated, 63 question measure featuring six domains relating to hand function, daily living, pain and aesthetics.
    - EQ-5D-5L: A validated, generic health status measure accompanied by a health status thermometer visual analogue scale (VAS).
    - Resource Use: Patient reported
    - Further Procedures: Clinician and Patient reported
    - Complications: Clinician and Patient reported
    - Recurrence: Assessed by clinicians during follow up visits, using the primary definition - change in extension deficit of 6 degrees between 3 and 6 months, or 20 degrees from 3 months to 1 year post treatment.
    - Extension deficit and total active movement: Assessed by clinicians during follow up visits.
    - Time to recovery of function: The SANE question, "From 0 – 100%, where do you put yourself currently in regards to your prior level of function?" collected from participants using postcards.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 3 months, 6 months, 1 year and 2 years after the intervention is delivered, with the exception of the SANE question which is also collected at 2 and 6 weeks. The Michigan Hand Question will only be collected on an annual basis after Baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Surgery (limited fasciectomy)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 this trial will be last visit last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 639
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state710
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 710
    F.4.2.2In the whole clinical trial 710
    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)
    Patients will return to routine care at the end of trial, which may include the use of collagenase to treat subsequent recurrence of Dupuytren's contracture.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network: East Midlands
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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