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    Summary
    EudraCT Number:2013-001701-85
    Sponsor's Protocol Code Number:AKT-001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-24
    Trial results Removed from public view
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-001701-85
    A.3Full title of the trial
    A placebo controlled, double blind, randomised, 8-week phase IIa proof of concept study to assess the efficacy and safety of AKR 202 in patients with osteoarthritis pain.
    Placebem kontrolované, dvojitě zaslepené, randomizované, 8-týdenní, koncepci prokazující klinické hodnocení fáze 2 pro posouzení účinnosti a bezpečnosti přípravku AKT 202 u pacientů s osteoartrotickou bolestí
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the safety and efficacy of AKR 202 with placebo in patients with osteoarthritis pain.
    A.4.1Sponsor's protocol code numberAKT-001
    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 SponsorAkron Molecules GmbH
    B.1.3.4CountryAustria
    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 supportAkron Molecules GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkron Molecules GmbH
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressHelmut-Qualtinger-Gasse 2
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1 236 0429
    B.5.5Fax number+43 1 23 60 429 99
    B.5.6E-mailclinical@akron-molecules.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 AKR 202
    D.3.4Pharmaceutical form Tablet
    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 INNADEFOVIR DIPIVOXIL
    D.3.9.1CAS number 142340-99-6
    D.3.9.2Current sponsor codeAKR 202
    D.3.9.4EV Substance CodeSUB12454MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 placeboTablet
    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
    Moderate to severe osteoarthritis pain in the index knee
    E.1.1.1Medical condition in easily understood language
    Moderate to severe osteoarthritis pain in the knee with most pain
    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 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 AKR 202 for the treatment of patients with moderate to severe osteoarthritis (OA) pain in the index knee
    E.2.2Secondary objectives of the trial
    To ssess the safety and tolerability of AKR 202 in patients with moderate to severe OA pain in the index knee.

    To assess further aspects of efficacy of AKR 202 (such as Patient Global Assessment, Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain subscale, stiffness, physical function scores)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide informed consent
    2. Patient is between 40 and 75 years of age
    3. Clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria
    4. Patient is of American Rheumatism Association (ARA) functional Class I, II, or III
    5. Patients should have an average pain level of between 4 and 8 on a Numeric Rating Scale (NRS) for at least 5 of 7 days before the randomisation, when answering the question: Please, rate the average pain in your index knee during the last 24 hours
    6. Patients should use pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opiods for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opiods at least 10 days out of 30 days during the last month prior to the screening visit)
    7. Female patients of childbearing potential must have a negative pregnancy test prior to study enrolment
    8. Patient is using adequate contraceptive measures from Visit 1 until 3 months after the last dose of IMP
    Female patients who have been post-menopausal for more than one year or female patients of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner])
    Male patients agreeing to use condoms during the study and for 3 months after the last dose of the IMP, or patients having a partner who is using a highly efficient method of contraception as described above
    9. Patient is willing to avoid unaccustomed physical activity for the duration of the study and follow-up period
    10. With the exception of OA, the patient is judged, by the Investigator, to be in good general health based on medical history, physical exam, and routine laboratory tests
    11. Patient is able to read, hear, understand, and complete study questionnaires, including questions requiring a NRS
    E.4Principal exclusion criteria
    1. Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
    2. Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the Investigator are sufficient to interfere with the conduct of the study
    3. Patient has a history of gastric or biliary surgery (including gastric bypass surgery), or small intestine surgery, either of which causes clinical malabsorption
    4. Patient has a history of Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), or positive viral test result for Hepatitis B or C or HIV 1 or 2
    5. Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with AKR 202 or any of its constituents
    6. Patient has an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impaire renal function
    7. Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure
    8. The patient has a history of uncontrolled hypertension or a current blood pressure that in the opinion of the Investigator makes the patient unsuitable for the study
    9. Patient has moderate or severe hepatic insufficiency defined as Child Pugh score >6, or serum transaminase levels (Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST]) of >1.5 X upper reference level for normal
    10. Patient has a history of neoplastic disease within the last 5 years, or a current neoplastic disease, with the exception of basal carcinoma
    11. Patient has a history of any illness, which in the opinion of the Investigator, might confound the results of the study or pose additional risk to the patient
    12. Patient has a history of alcohol or substance abuse
    Patient is, at the time of screening, a user of recreational or illicit drugs or has had a recent history (within the last 2 years) of drug or alcohol abuse or dependence. Or the patient has a currently weekly alcohol consumption of >14 units for females and >21 units for males
    13. Patients considered morbidly obese with a Body Mass Index (BMI) ≥40 kg/m2
    14. Patient has (within 4 weeks of the screening visit ,Visit 1) started or changed the following non medical treatment: physical medicine modalities involving the study joint, including but not limited to: physical therapy, chiropractic interventions, acupuncture, herbal medication administered for OA, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound
    15. Patients with a trauma or surgery at the index knee within 3 month prior to screening (Visit 1)
    16. Patient is expected to undergo in-patient hospitalisation or any planned surgery during the course of the study
    17. Patients using oral or injectable steroids or other immunosuppressant medication within 2 months prior to screening (Visit 1)
    18. Patients using corticosteroid, hyaluronic acid or Autologous Conditioned Plasma (ACP) injections to any joint within 2 months prior to screening (Visit 1)
    19. Patients using topical or systemic analgesic medications not allowed in the study protocol at any time during the study, with the exception of low-dose aspirin (≤325 mg/day) used for prophylaxis of cardiovascular events
    20. Patients with clinically significant abnormalities, as judged by the Investigator, on Visit 1 clinical examination or laboratory safety tests
    21. Patients currently participating in or has participated in a study with an investigational drug or device within 4 weeks prior to screening (Visit 1)
    22. Female patients: currently pregnant or breast-feeding or intending to become pregnant within 3 months after last dose of IMP or intending to donate ova during such time period
    23. Use of strong opioids or other central acting drugs for analgesic purposes within the 3 months prior to screening (Visit 1)
    24. Previous or current prescribed use of strong opioids for the treatment of pain due to OA
    25. Previous or current use of Nerve Growth Factors (NGF)
    26. Donation of blood or plasma 12 weeks prior to or planned during the study period, including the 4 week follow-up period.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in WOMAC pain subscale at Week 8 or at the final visit at the time of patient discontinuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint: Week 8 or at the final visit at the time of patient discontinuation
    E.5.2Secondary end point(s)
    • Change from baseline in the Patient Global Assessment at Week 4 and Week 8 or at the final visit at the time of patient discontinuation
    • Change from baseline in WOMAC pain subscale at Week 4 or at the final visit at the time of patient discontinuation
    • Change from baseline in the WOMAC OA function subscale score at Week 4 and Week 8 or at the final visit at the time of patient discontinuation
    • Change from baseline in the WOMAC OA Index stiffness subscale score at Week 4 and Week 8 or at the final visit at the time of patient discontinuation
    • Change from baseline in the total WOMAC OA Index pain, stiffness and physical function subscale score at Week 4 and Week 8 or at the final visit at the time of patient discontinuation
    • Change from baseline for each of the WOMAC OA questions at Week 4 and Week 8 or at final visit at the time of patient discontinuation
    • Proportion of patients with a reduction of 50% and more and an absolute decrease of 2 points or more in WOMAC pain or physical function sub scales, or two of the following three findings:
    o A decrease in WOMAC pain subscale by 20% or more and an absolute reduction by 1 point or more
    o A decrease in WOMAC physical function subscale by 20% or more and an absolute reduction by 1 point or more
    o A decrease in patients global assessment by 20% or more and an absolute reduction by 1 point or more
    • Pain rating captured on a NRS by daily questions through the IVRS during 7 days before the baseline visit and during 7 days before the Week 8 visit by answering the following questions: 1) Please, rate the average pain in your index knee during the last 24 hours; 2) Please, rate the worst pain in your index knee during the last 24 hours
    • Pain rating captured on a NRS at the baseline visit, the Week 4 visit and the Week 8 visit by answering the following questions: 1) Please, rate the average pain in your index knee during the last 24 hours; 2) Please, rate the worst pain in your index knee during the last 24 hours.
    • Use and amount of rescue medication: Compliance/accountability check at the clinic visits Week 4 and Week 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint: Week 4 and/or week 8 and/or at the final visit at the time of patient discontinuation
    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.8.2.4Number 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    The end of study is defined as the date of the last patient’s last follow up call
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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 Decision2013-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-10
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