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    Summary
    EudraCT Number:2014-000717-31
    Sponsor's Protocol Code Number:WI187847
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-12
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-000717-31
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study of celecoxib after collagenase injection for adults with Dupuytren’s disease at high risk of recurrence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    celecoxib after collagenase injection in Dupuytren's disease
    A.4.1Sponsor's protocol code numberWI187847
    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 SponsorUZ Leuven
    B.1.3.4CountryBelgium
    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 supportPfizer
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrthosearch
    B.5.2Functional name of contact pointClinial Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWeligerveld 1
    B.5.3.2Town/ cityPellenberg
    B.5.3.4CountryBelgium
    B.5.4Telephone number003216338817
    B.5.6E-mailorthopedic.research@uz.kuleuven.be
    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 Celebrex
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCelebrex
    D.3.2Product code LI900005
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dupuytren's disease
    E.1.1.1Medical condition in easily understood language
    Dupuytren's disease is a fibroproliferative disease causing important palmar contractures of the fingers
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10051062
    E.1.2Term Wrist surgery
    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
    The purpose of this study is to evaluate the ability of celecoxib to improve the treatment result (improved finger extension) of collagenase in Dupuytren’s patients at high risk for disease recurrence, when administered after the collagenase injection.
    E.2.2Secondary objectives of the trial
    A. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: ≥ 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED.

    C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient.
    D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Dupuytren’s patients with risk score D of Abe1 > 4.
    Dupuytren’s diathesis, and thus risk for recurrence or extension after surgery, is evaluated according to the D-score (diathesis) formulated by Abe1: (a) bilateral hand involvement ( with = 1, without = 0), (b) little finger surgery ( with = 1, without = 0), (c) early onset before the age of 50years (1-0), (d) plantar fibrosis (2-0), (e) knuckle pads (2-0) and (f) radial side involvement (2-0). D = a + b + c + d + e + f. If the D-score is higher than 4, there is a high risk of recurrence and extension.
    Patients must be scheduled to undergo treatment with collagenase injections.
    Age > 18 years at the time of the informed consent.
    E.4Principal exclusion criteria
    Exclusion criteria or contra-indications as per Summary of Product Characteristics (appendix 9).
     Current administration of another NSAID or anticoagulant.
     History or evidence of any other clinically significant disorder, malignancies, condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
     Patient likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures.
     Known exclusion criteria to celecoxib (see appendix 9 for patient leaflet)
    E.5 End points
    E.5.1Primary end point(s)
    A. The Total Passive Extension Deficit (TPED) of the MCP, PIP and DIP joints of each affected ray will be measured with an electronic goniometer, by two independent orthopaedic surgeons. The study will focus on individual rays, rather than on patients, especially for computation of the data. This TPED will be measured before surgery (clinical data sheet) and 4 and 12 weeks, 6 months, 1 and 2 years after surgery. Clinical pictures will be made preoperatively and at every follow-up evaluation (palmar view and ulnar view, as a back-up).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dec 2018
    E.5.2Secondary end point(s)
    B. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: ≥ 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED.

    C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient.
    D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Dec 2018
    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 No
    E.6.5Efficacy No
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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 No
    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
    June 2018
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-27
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