Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-001769-34
    Sponsor's Protocol Code Number:102-240-02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-001769-34
    A.3Full title of the trial
    A double-blind, placebo controlled, parallel-group, randomised study of safety, tolerability and efficacy of AMAP102 in patients with osteoarthritis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety, tolerability and efficacy of AMAP102 compared to placebo in patients with osteoarthritis
    A.4.1Sponsor's protocol code number102-240-02
    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 SponsorAnaMar AB
    B.1.3.4CountrySweden
    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 supportAnaMar AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnaMar AB
    B.5.2Functional name of contact pointAnna-Carin Ryde
    B.5.3 Address:
    B.5.3.1Street AddressSölvegatan 41
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 70
    B.5.3.4CountrySweden
    B.5.4Telephone number464610 13 57
    B.5.5Fax number46462863540
    B.5.6E-mailAnna-Carin.Ryde@anamar.com
    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.3.2Product code AMAP102
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMAP102
    D.3.9.2Current sponsor codeAMAP102
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    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
    Osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10019115
    E.1.2Term Hand osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 efficacy of AMAP102 in patients with pain secondary to osteoarthritis (OA) over 28 days of dosing
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of AMAP102 in OA patients.
    • To assess the safety and tolerability of AMAP102 in OA patients.
    • To measure the plasma concentrations of AMAP102 in OA patients.
    • To explore the effects of AMAP102 on interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF α), cartilage oligomeric matrix protein (COMP), and serotonin (5-HT) in OA patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female outpatients aged ≥ 50 years.
    2. Male or female outpatients with a body mass index of 18 to 30 kg/m2 and a minimum weight of 50 kg.
    3. Patients with a clinical diagnosis of unilateral or bilateral knee OA based on clinical and radiographic criteria. Patients should fulfill the validated criteria for the classification of primary OA, published by the American College of Rheumatology (ACR):
    • The ACR Classification Criteria (1986) for clinical and radiographic OA of the knee are:
    - Knee pain.
    - Osteophytes
    - And one of the following:
    o Age ≥ 50 years.
    o Stiffness of < 30 minutes upon rising in the morning.
    o Crepitus.
    4. Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol at a dose suggested by the European Medicines Agency-approved over-the-counter/prescription labelling on a regular basis (approximately 20 of the past 30 days) prior to the screening visit and with a history of knee pain treatment response with NSAID or paracetamol use.
    5. Patients with mild to moderate OA of the knee at the screening visit (Visit 1). Mild to moderate OA of the knee is defined using the following criteria:
    • Mild: mild symptoms (no limitations of normal activities).
    • Moderate: moderate symptoms (limitation of some normal activities).
    • Severe: severe symptoms (inability to carry out most normal activities).
    • Extreme: very severe symptoms (inability to carry out all normal activities).
    6. Patients with arthritis ‘flare’ in the target knee within 12 days of withdrawing from NSAID or paracetamol. Flare, by definition, must meet the criteria described below and the patient should be randomised as soon as these criteria are met:
    • Minimum score of 5 or greater on the 11-item NRS for the patient’s overall pain intensity during activity in the target knee for the last 24 hours on 2 consecutive days, taken from patient’s diary and a score of 5 or greater in the target knee at Visit 2 (baseline).
    • Increase of at least 2 on the NRS for the patient’s overall pain intensity during activity in the target knee within the last 24 hours when compared with the value obtained at the screening visit (Visit 1).
    7. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures.
    8. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
    9. The ability to swallow and retain all of the investigational medicinal product.
    E.4Principal exclusion criteria
    1.The patient has primary inflammatory diseases of the joint (e.g.rheumatoid arthritis,psoriatic arthritis,Reiter’s syndrome,arthritis of inflammatory spondyloarthropathy or inflammatory bowel disease, or infectious arthritis).
    2.The patient has unstable knees including a history of the knee catching or giving way and/or physical examination evidence of instability (e.g.positive posterior drawer sign,positive Lachman,positive anterior drawer sign,medial or lateral collateral ligament instability,etc).
    3.The patient has arthropathies that occur in conjunction with systemic diseases such as chondrocalcinosis,chondromatosis,gout,pseudo gout,haemophilia,or collagen vascular disease.
    4.The patient has a chronic pain condition (e.g.somatisation disorders,chronic headache,fibromyalgia,etc).The patient has chronic lower back pain (individual cases should be discussed with the Medical Monitor) that could confound the analgesic response of the study medication.
    5.The patient has a history of knee surgery within the past 12 months,arthroscopy within the past 6 months,or is anticipated to undergo knee surgery in next 3 months or general surgery during the time of participation in the study.
    6.The patient has advanced joint damage (Kellgren-Lawrence grade 4); or,in the opinion of the investigator,the patient has advanced joint damage assessed without an X-ray.
    7.The patient has a history of osteotomies.
    8.The patient is using any of the prohibited medications that are listed in Table 3 of the protocol.
    9.The patient used opioids (e.g.codeine,propoxyphene,or combinations of these drugs with NSAIDs or paracetamol) for OA pain within 1 month or 5 half-lives of the drug (whichever is longer) prior to the screening visit (Visit 1).
    10.The patient received intra-articular injections of sodium hyaluronate agents within 6 months or 5 half lives of the drug (whichever is longer) before the screening visit (Visit 1) or steroids in joints other than the knee or intravenous or intramuscular steroids within 2 months or 5 half-lives of the drug (whichever is longer) before the screening visit (Visit 1).
    11.The patient used oral steroids,intra-articular steroids in the knee, or other immunosuppressant medications within 2 months or 5 half-lives of the drug (whichever is longer) before the screening visit (Visit 1).
    12.The patient received methotrexate within 30 days before the screening visit (Visit 1).
    13.The patient must agree not to take rescue medication (paracetamol) between the screening visit and baseline, and for 24 hours before any clinic visit.
    14.The patient has significant renal impairment (defined as a serum creatinine > 2 x upper limit of normal [ULN] or creatinine clearance < 30 mL/min), liver enzymes elevated > 3 x ULN, positive class III/IV angina or uncontrolled congestive heart failure in the opinion of the investigator, significant active hepatic disease, history of malignant neoplastic disease (other than basal cell carcinoma of the skin) within the past 5 years, or a current severe infectious disease with or without fever.
    15.The patient is a woman of childbearing potential who has a positive serum pregnancy test or is a nursing mother. The patient is not surgically sterile (by tubal ligation or hysterectomy) or at least 2 years postmenopausal and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months before the screening visit (Visit 1).
    16.The patient has a clinically significant psychiatric condition or history of substance abuse or dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV within 1 year before the screening visit (Visit 1), which in the opinion of the investigator may interfere with participation in the study.
    17.The patient has a score of 14 or higher on the Beck II Depression Inventory at the screening visit (Visit 1).
    18.The patient received another investigational drug or device or participated in any other clinical study within 1 month or 5 half-lives of the drug (whichever is longer) before the screening visit (Visit 1).
    19.The patient has a heavy alcohol consumption rate (i.e., more than 35 units per week or 8 units per day for men, or more than 24 units per week or 6 units per day for women; 1 unit is defined as 35 cL beer, 6 cL hard alcohol, or 18 cL wine).
    20.The patient is an employee, or family member of an employee, of the study centre, the CRO (PRA), or the Sponsor (AnaMar AB) involved in this study.
    21.The patient is unsuitable to participate in the study in the opinion of the investigator.
    22.The patient answers yes to either question 4 or 5 of the screening visit version of the C-SSRS.
    23.The patient has a history of dysrhythmias (e.g., bradycardia or tachycardia) or any clinical significant cardiac disease.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: WOMAC Pain subscale for the target knee.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint: at Visit 2 (Day 1) Visit 3 (Day 7), Visit 4 (Day 14) and Visit 5 (Day 28)
    E.5.2Secondary end point(s)
    • Daily 24-hour average pain during activity score in the target knee measured with the NRS from the patient’s daily diary.
    • Daily 24-hour average pain score in the target knee measured with the NRS from the patient’s daily diary.
    • Daily 24-hour average worst pain score in the target knee measured with the NRS from the patient’s daily diary.
    • Daily cumulative proportion of responders from baseline to on average 24-hour pain during activity scores in the target knee assessed with the NRS from the patient’s daily diaries. A responder is defined as a patient who achieves and maintains a 30% improvement in the average 24-hour pain during activity scores over baseline until the end of the study.
    • Number of responders, defined as patients who achieve and maintain a 30% improvement in the average 24-hour pain during activity scores in the target knee over baseline until the end of the study.
    • Average daily and weekly use and total use of rescue medication (paracetamol).
    • Daily quality of sleep rating assessed by the Modified Pittsburgh Sleep Quality Index.
    • WOMAC Stiffness subscale for the target knee.
    • WOMAC Physical Functioning subscale for the target knee.
    • WOMAC total score for the target knee.
    • Patient global assessment of study drug satisfaction.
    • Investigator global assessment of study drug satisfaction.
    • EQ-5D-5L™.
    • Serum hsCRP levels.

    Safety Endpoints: Safety will be assessed using incidence of all adverse events, serious adverse events and those leading to withdrawal of study medication, review of clinical laboratory assessments (haematology, clinical chemistry and urinalysis), concomitant medications, ECG monitoring, physical examinations, vital signs, body weight and C-SSRS.

    Pharmacokinetic Endpoints:
    • Plasma AMAP102 concentrations at Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 28) and Visit 6 (Day 35) after b.i.d. dosing in each treatment group.
    • The proportion of patients in each treatment group showing measurable amounts of AMAP102 at Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 28) and Visit 6 (Day 35).

    Exploratory Endpoints:
    • Serum IL-6, TNF-α and COMP and serum and plasma 5-HT levels at Visit 2 (Day 1), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 28) and Visit 6 (Day 35).
    • AUSCAN Pain subscale for the target hand.
    • Daily 24-hour average pain during activity score in the target hand measured with the NRS from the patient’s daily diary.
    •Daily 24-hour average pain score in the target hand measured with the NRS from the patient’s daily diary.
    • Daily 24-hour average worst pain score in the target hand measured with the NRS from the patient’s daily diary.
    • Daily cumulative proportion of responders from baseline on average 24 hour pain during activity scores in the target hand assessed with the NRS from the patient’s daily diaries. A responder is defined as a patient who achieves and maintains a 30% improvement in the average 24-hour during activity pain scores over baseline until the end of the study.
    • Number of responders, defined as patients who achieve and maintain a 30% improvement in the average 24-hour pain during activity scores in the target hand over baseline until the end of the study.
    • AUSCAN Stiffness subscale for the target hand.
    • AUSCAN Physical Functioning subscale for the target hand.
    • AUSCAN total score for the target hand.
    Note: the AUSCAN and NRS endpoints for the target hand will only be assessed on the sub population of patients with arthritis ‘flare’ in the target hand (Appendix 2: Definition of the Target Joint) at the baseline visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AUSCAN Pain subscale-at Visits 2, 3, 4 & 5
    Average pain in target knee, at rest & during activity-Daily
    Average pain in target hand at rest & during activity-Daily
    Worst pain in target knee & hand-Daily
    Rescue medication use-Daily
    Quality of sleep-Daily
    AUSCAN Stiffness & Physical Functioning subscales & total score for target hand-at Visits 2, 3, 4 & 5.
    WOMAC Physical Functioning subscale & total score for the target knee at Visits 2, 3, 4 & 5
    Patient & Investigator global assessment of study drug satisfaction - at Visits 3, 4 & 5
    EQ-5D-5L™ - at Visits 2, 3, 4 & 5
    Serum hsCRP levels - at Visits 2, 3, 4, 5 & 6
    Safety Endpoints: ongoing
    Pharmacokinetic Endpoints: at Visits 3, 4, 5 & 6
    Explorative Laboratory Endpoints: at Visits 2, 3, 4, 5 & 6
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months19
    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 months19
    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 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: 90
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Standard of care normal treatment
    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 Decision2012-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 11:46:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA