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    The EU Clinical Trials Register currently displays   43846   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).

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    Summary
    EudraCT Number:2007-002417-39
    Sponsor's Protocol Code Number:ONO-5334POE003
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-002417-39
    A.3Full title of the trial
    A MULTI-CENTRE RANDOMISED DOUBLE BLIND, PLACEBO AND ACTIVE CONTROLLED PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-5334 IN POST MENOPAUSAL WOMEN WITH OSTEOPENIA OR OSTEOPOROSIS
    A.4.1Sponsor's protocol code numberONO-5334POE003
    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 SponsorOno Pharmaceutical Co., Ltd.
    B.1.3.4CountryJapan
    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 nameONO-5334
    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 620614-15-5
    D.3.9.2Current sponsor codeONO-5334
    D.3.9.3Other descriptive nameN-((1S)-3-{(2Z)-2-[(4R)-3,4-Dimethyl-1,3-thiazolidin-2-ylidene]hydrazino}-2,3-dioxo-1-(tetrahydro-2H
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeONO-5334
    D.3.9.3Other descriptive nameN-((1S)-3-{(2Z)-2-[(4R)-3,4-Dimethyl-1,3-thiazolidin-2-ylidene]hydrazino}-2,3-dioxo-1-(tetrahydro-2H
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Fosamax Once Weekly®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAlendronate
    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.3.9.2Current sponsor codeAlendronate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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
    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
    Osteoporosis or Osteopenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049088
    E.1.2Term Osteopenia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to compare the percentage change in DXA BMD of the lumbar spine between baseline and 12 months following treatment with ONO-5334 or placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial will be:
    • To compare the effect of ONO-5334 or once weekly Alendronate (Fosamax Once Weekly®) versus placebo on DXA BMD and BMC (Lumbar spine, Total hip, Femoral neck and Trochanter) and biochemical markers of bone turnover from baseline during the course of treatment.
    • To compare the proportions of responders to ONO-5334 or Alendronate therapy at the end of treatment compared with placebo.
    • To compare the safety and tolerability of ONO-5334 or Alendronate versus placebo.
    • To compare compliance with treatment with ONO-5334 or Alendronate versus placebo.
    • To compare the efficacy and safety of ONO-5334 versus Alendronate.
    • To investigate the efficacy and safety of three different doses of ONO-5334 (50mg BID, 100mg QD, 300mg QD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Post menopausal women aged between 55 and 75 years old inclusive (55 ≤ age ≤ 75). Post menopausal is defined as more than 5 years after menopause and with Oestradiol and FSH levels consistent with menopause (FSH > 30IU/L, Oestradiol <92pmol/L),
    2. Osteoporosis defined as a value of DXA BMD 2.5 standard deviations or more below the young adult mean (T-score ≤ -2.5) at the lumbar spine (L1 to L4) or total hip in the absence of any fragility fractures,
    OR,
    Osteopenia defined as a value of DXA BMD more than 1 standard deviation below the young adult mean, but less than 2.5 standard deviations below this value (T-score <-1 and >-2.5) at the lumbar spine (L1 to L4) or total hip with the presence of one or more fragility fractures.
    3. Able and willing to give written informed consent.
    E.4Principal exclusion criteria
    1. Patients with a value of DXA BMD more than 3.5 standard deviation below the young adult mean, (T-score < -3.5) at the lumbar spine (L1 to L4) or total hip.
    2. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD. e.g.,
    A) Patients who have severe scoliosis.
    B) Patients who have two or more vertebral levels in L1, L2, L3, L4 that are not evaluable by DXA due to fracture, metal implants or other orthopaedic procedures etc.,
    C) Patients who have a previous fracture, severe deformity or metal pins, plates, prostheses, etc., affecting either femur.
    D) Patients who have severe osteoarthritis (oeteophytes, sclerosis, etc.) in L1, L2, L3, L4 or femoral neck
    E) Patients who have severe aortic calcification interfering with spinal BMD measurement.
    3. Patients who have experienced clinical fractures one year prior to the Randomisation visit (Visit 1).
    4. Patients who have secondary causes of osteoporosis. e.g.,
    A) Endocrine disorders: thyrotoxicosis, primary hyperparathyroidism, Cushing’s syndrome
    B) Rheumatologic conditions: rheumatoid arthritis, ankylosing spondylitis
    C) Gastro-intestinal disorders: malabsorption partial gastrectomy
    D) Malignancy: multiple myeloma, metatastic carcinoma
    E) Drug treatment: systemic oral glucocorticoids, methotrexate, heparin, anti-convulsants
    F) Genetic disorders: osteogenesis imperfecta
    G) Nutritional deficiencies: osteomalacia or anorexia
    H) Immobility
    I) Other conditions: Diabetes (patients with IDDM, insulin treated or HbA1c ≥8.0%), hepatic impairment (defined by the exclusion criteria 8), alcoholism (≥20 unit per week)
    5. Patients who have other disorders of bone and mineral metabolism. e.g.,
    A) Vitamin D deficiency (defined as serum 25 hydroxy vitamin D value < 10 ng/mL)
    B) Hypocalcemia (defined as serum Calcium < 8.5 mg/dL)
    C) Paget’s disease of bone
    D) Controlled or uncontrolled hypo- or hyperthyroidism, hypo or hyperparathyroidism, hypo- or hypercalcemia
    E) Osteomalacia, or osteogenesis imperfecta
    6. Patients for whom once weekly Alendronate treatment is contraindicated.
    7. Patients with low bone turnover defined as urinary CTX-I below 200μg /mmolCr at the Screening visit.
    8. Patients who have history or presence of other significant disease, which in the opinion of the Investigator, might compromise the patient’s safety or the evaluation of the study results.
    9. A history of drug or alcohol abuse (alcoholic patients who are recovered for at least 2 years will be allowed to enrol in this study).
    10. Patients who have history of malignancy within the past 5 years of the Screening visit.
    11. Patients with impaired hepatic function defined as raised liver function tests (aspartate transaminase, alanine transaminase, alkaline phosphatase) greater than 2.5 times upper limit of laboratory normal.
    12. Patients with impaired renal function defined as calculated creatinine clearance < 35mL/min based upon the value derived from the Cockcroft and Gault equation.
    13. Any previous use of PTH and its derivatives, Strontium or Fluoride including ones in development before Screening visit.
    14. Use of bisphosphonates in the three years preceding the Screening visit.
    15. Use of HRT, SERMs, Calcitonin, Anabolic steroids, Thiazides, Vitamin K or any medication that may in the opinion of the Investigator have an effect on bone metabolism in the preceding one year of the Screening visit.
    16. Use of Antacids, Systemic oral glucocorticoids, High daily dose of inhaled glucocorticoids, Methotrexate, Systemic heparin or Anti-convulsant in the preceding one year of the Screening visit.
    17. Poor medication compliance: defined as taking <80% of the elemental calcium and vitamin D dose scheduled between the Screening visit and the Randomisation visit (Visit 1).
    18. Patients who have used any investigational drug and/or participated in any clinical trial within 3 months of the Screening visit.
    19. Patients who have previously received ONO-5334.
    20. In the opinion of the Investigator, the patient may not be able to cooperate fully with the study staff, may have difficulty following some requirements, or is otherwise not qualified for the study.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the percentage change in DXA BMD of the lumbar spine between baseline and 12 months following treatment with ONO-5334 or placebo
    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) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Yes
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 265
    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 Decision2007-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
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