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    Summary
    EudraCT Number:2007-001457-26
    Sponsor's Protocol Code Number:A6171016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-001457-26
    A.3Full title of the trial
    A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, RADIOGRAPHIC STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED SD-6010 IN SUBJECTS WITH SYMPTOMATIC OSTEOARTHRITIS OF THE KNEE
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberA6171016
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorPFIZER
    B.1.3.4CountryItaly
    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 nameSD-6010
    D.3.2Product code PHA-728669F
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 753491-31-5
    D.3.9.2Current sponsor codeSD-6010/PHA-728669F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 nameSD-6010
    D.3.2Product code PHA-728669F
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 753491-31-5
    D.3.9.2Current sponsor codeSD-6010/PHA-728669F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    D.8 Placebo: 2
    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
    Osteoarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the disease modifying efficacy of SD-6010 50 mg and 200 mg QD compared to placebo in reducing the rate of progression of OA as assessed by radiographic JSN in the medial tibiofemoral compartment of the study knee of obese women with knee OA.
    E.2.2Secondary objectives of the trial
    1. To assess the safety and tolerability of SD-6010 50 mg and 200 mg QD administered long-term to obese women with knee OA; 2. To assess the clinical benefit of SD-6010 50 mg and 200 mg QD in obese women with knee OA as measured by the clinical endpoints including, but not limited to, WOMAC, pain VAS (visual analog scale), changes in background pain therapy and use of rescue medication in the study knee.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOGENETICA
    E.3Principal inclusion criteria
    1. Has provided written informed consent and is willing to comply with scheduled visits, treatment plan, radiographs, laboratory tests, and other trial procedures; 2. Is a female aged >/=40 years with a BMI >/=30 and <40 kg/m2; 3. In the past, has been diagnosed with knee OA and has had knee symptoms in the past year defined as: Pain, aching or stiffness on most days of a month; and/or Used a medication (other than potent opioids) for treatment of knee pain on most days of a month; 4. Has a current level of pain (outside of acute flare) in at least 1 knee characterized by a WOMAC Pain subscale score of between 6 and 12, inclusive (where the range of subscores is 0-20); Note: Pain must be characterized as a subject’s normal day-to-day pain while on standard of care medication and not the pain associated with an acute flare. 5. Has been on the same standard of care medication(s) for OA pain in the knee(s) for at least 3 months and on a stable dosing regimen for at least 4 weeks preceding the first dose of study medication (stable defined as: Doses and frequency of administration remain unchanged); 6. Is of non-childbearing potential, if 1 of the 2 categories below is satisfied: Is >/=45 years of age and amenorrheic for at least 2 years, or Has proof of a physician documented hysterectomy and/or bilateral oophorectomy; Note: Females not meeting the non-childbearing rules above or having undergone tubal ligation will be considered of childbearing potential for this study (refer to n.next). 7. If of childbearing potential, has agreed that when sexually active, to use the protocol designated effective methods of contraception and abide by the time frames described in Section 4.5.1.1; Subjects meeting the following Screen 1 inclusion criteria by radiography as assessed through the modified Lyon-schuss X-ray will be semi-qualified for Screen 2. Criteria 1-6 below will be assessed by the independent Central Reader and communicated back to the Central Imaging Core Laboratory, which will then assess the results against the OA history taken at the Screen 1 visit as the final step in determining which subjects will be invited back for Screen 2. A “yes” answer to each criterion is needed to continue screening. 1. A KLG 2 or 3 AND a medial tibiofemoral minimum JSW >/=2 mm in the study knee; 2. A KLG <4 in the contralateral knee; 3. An anatomic axis angle between 184 and 174 degrees inclusive in the study knee; 4. The lateral minimum joint space width (JSW) > the medial minimum JSW in the study knee; 5. No radiological findings such as, but not limited to avascular necrosis, fracture, infection, gout, Paget’s disease, osteopetrosis, osteochondritis, or other pathologies in the study knee.
    E.4Principal exclusion criteria
    1. Subjects with a history of: a. A diagnosis of any other rheumatic disease (eg, spondyloarthropathies, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, etc.); b. Current, severe, uncontrolled renal*, hepatic, hematological, gastrointestinal,metabolic, endocrine, pulmonary, cardiac, neurological disease, or any other condition which would make the subject unsuitable for the study within 6 months preceding the Screen 1 visit; * Controlled renal dialysis patients will be excluded. c. Uncontrolled diabetes, uncontrolled hyperglycemia, active foot wound infection, or a history of diabetic ulceration; d. Clinically significant infections (acute infection or those requiring hospitalization or requiring parenteral antimicrobial therapy) within 6 months preceding the Screen 1 visit; e. An active malignancy of any type or history of a malignancy (with the exception of subjects with malignancy surgically removed with no evidence of recurrence within the past 5 years, and with the exception of subjects with a history of treated nonmelanoma carcinoma); f. Any known diseases or conditions that may involve the knees including, but not limited to crystalline disease (eg, gout, pseudogout),endocrinopathies (eg, acromegaly), metabolic diseases (eg, ochronosis, hemochromatosis, Wilson’s disease, Gaucher’s disease), septic arthritis, neuropathic disorders, mechanical disorders (eg, hypermobility), avascular necrosis, intra-articular fracture, microfractures, cartilaginous debridment, chondrocyte transplantation, osteotomy, arthroplasty, mosaicplasty, ACL rupture, partial or total meniscectomy, osteophyte resection, or any other tissue-related injuries to the knees, Paget’s disease, tumors, (eg, primary osteochondromatosis), or collagen gene mutations; g. Significant trauma to the knees (including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the Screen 1 visit; h. Alcoholism or drug abuse within 1 year preceding the Screen 1 visit; 2. Subjects presenting with: a. A verified systolic blood pressure >150 mm Hg (if untreated for hypertension) or greater than 160 mm Hg (if treated for hypertension) and/or a diastolic bloodpressure greater than 90 mm Hg; b. An ECG finding considered by the Investigator to be clinically significant; c. Any morbidities (eg, coronary heart disease, hypertension, dyspnea, diabetes, obesity, COPD, emphysema, depression, severe OA) that would curtail workrelated or leisure time physical activities (eg, walking, cooking, gardening, standing) such that these morbidities would contribute to increases in sedentary behaviors (eg, becoming chair- or bed-ridden, aka, “couch potato lifestyle”); d. Chronic potent opioid use(propoxyphene, tramadol, codeine use is acceptable); e. Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy); f. Anticipated need for knee or hip surgery in the next 2 years; g. Exacerbation of OA pain (eg, a flare) in either knee requiring a change in stable treatment within 4 weeks of the Screen 1 visit; h. Symptomatic OA of either hip by history or elicited on physical examination that may confound the interpretation of knee pain; i. Clinically significant non-articular musculoskeletal pain that cannot be distinguished from knee OA and would interfere with the study assessments of efficacy (eg, anserine bursitis, prepatellar bursitis, nerve entrapment syndrome,reflex sympathetic dystrophy, intermittent claudication or complex regional pain syndrome); j. Oral or intramuscular corticosteroid use or intra-articular steroid use in the knees within 12 weeks preceding the Screen 1 visit;
    E.5 End points
    E.5.1Primary end point(s)
    The progression rate of JSN.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-04-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 421
    F.4.2.2In the whole clinical trial 1400
    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 Decision2008-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-09
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