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    Summary
    EudraCT Number:2004-004885-33
    Sponsor's Protocol Code Number:04/4
    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:2008-06-24
    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 number2004-004885-33
    A.3Full title of the trial
    Topical treatment of hand osteoarthritis with glucosamine cream.
    A.4.1Sponsor's protocol code number04/4
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBio Minerals n.v.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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 No
    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 nameWinFlex cream
    D.3.2Product code 0904-277
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNglucosamine sulphate
    D.3.9.1CAS number 3416-24-8
    D.3.9.2Current sponsor code0903-264
    D.3.9.3Other descriptive nameglucosamine sulphate potassium chloride
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    osteoarthritis of the hands
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the global pain intensity in the target hand measured on a 100 mm VAS, respectively after 2 and 4 weeks treatment.
    E.2.2Secondary objectives of the trial
    The secondary outcome measures are:
     The response to treatment, defined by the OARSI (OsteoArthritis Research Society International) and the OMERACT (Outcome Measures in Rheumatology) committees
     The change in the AUSCAN pain subscale from baseline to respectively 2 and 4 weeks treatment.
     The response to treatment, defined as 30% decrease in the AUSCAN pain subscale from baseline to 2 and 4 weeks.
     The change in AUSCAN joint stiffness, and physical function subscales from baseline to respectively 2 and 4 weeks treatment.
     The change in palpation pain evaluated by the Ritchie scale for the target hand from baseline to respectively 2 and 4 weeks treatment.
     The change in grip strength measured by dynamometry for the target hand from baseline to respectively 2 and 4 weeks treatment.
     The use of paracetamol as rescue medication measured by checking compliance, from baseline to respectively 2 and 4 weeks treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of either sex
    - Age > 30 years
    - Providing of written informed consent.
    - Patients with hand osteoarthritis according to the diagnostic criteria of the American College of Rheumatology
    - Patients with primary (non-erosive and erosive OA) and post-traumatic (due only to remote [> 6 months ago] trauma).
    - Patients with thumb OA
    - On entry, a global hand pain score in the target hand of at least 40 mm on a 100 mm visual analogue scale (VAS), after withdrawal of other analgesic/anti-inflammatory medications.
    - Patients who are taking paracetamol (as rescue medication) are allowed to participate in the trial.
    - Minimum symptom duration: pain should have been present for at least half of the days in the previous month (i.e. pain should have been present for at least 15 days in the previous month) and for at least 48 hours prior to inclusion visit (T0).
    E.4Principal exclusion criteria
    - Patient unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols.
    - Unlikely to co-operate fully in the study.
    - Alcohol (e.g. more than 28 units per week) or drug abuse.
    - Pregnancy or breastfeeding women.
    - Patients with a swollen or warm joint thought to be secondary to gout, pseudogout or sepsis.
    - Clinically significant medical abnormalities, which would make the patient unsuitable for the study as judged by the investigator.
    - The patient has a fracture or malignant tumor at the hands. Significant injury to the affected joint within 6 months of trial start. Disease upper extremity joints of sufficient degree to affect assessment of the target joint. Presence of OA secondary to known disorders other that remote (> 6 months ago) trauma.
    - Poor general health interfering with compliance or assessment
    - Less than 1 month between the time of IA injection of depocorticosteroid and enrollment.
    - Less than 6 months between the time of IA injection of a hyaluronate and enrollment.
    - Patients with symptomatic knee OA.
    - Use of assistive devices such as a cane or crutch.
    - Less than 3 months between the treatment with a slow acting drug for symptom relief and enrollment
    - Concomitant and previous medication:
     Use (topical, systemic, intra-articular) of hyaluronic acid, glucosamine sulphate, glucosamine HCl, n-acetyl glucosamine and derivatives thereof such as chondroitin sulphate, glycosaminoglycans.
     Patients who have used previous topical and/or systemic treatment with NSAID’s or analgetica, different from paracetamol, such as ibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study
     Patients who have used medications with MMP-inhibitory properties (e.g. tetracyclines or structurally related compounds), or took oral (systemic, > 10 days duration) glucocorticoids in a 28 days period prior to start of the study.
     Patients who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein, glucosamine and/or chondroitin sulfate containing compounds) in a 28 days period prior to start of the study.
    - Treatment during the trial with physical and/or occupational therapy.
    - Known allergy against glucosamine or any of the ingredients in the cream.
    - Open wounds at the hands.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is:
    The global pain intensity in the target hand measured on a 100 mm VAS, respectively after 2 and 4 weeks treatment.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 Yes
    E.8.2.3Other No
    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 concerned2
    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 Information not present in EudraCT
    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
    End of the trial is the date of the last visit of the last patient undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state300
    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)
    expected normal treatment for this condition
    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 Decision2008-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
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