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    Summary
    EudraCT Number:2015-004269-96
    Sponsor's Protocol Code Number:IG8801CLBP201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-24
    Trial 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 number2015-004269-96
    A.3Full title of the trial
    A 24 weeks multicentre, randomized, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy, safety and tolerability of intravenous IG-8801 20 mg and 40 mg in subjects with chronic low back pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olpadronate intra venous in chronic low back pain
    A.4.1Sponsor's protocol code numberIG8801CLBP201
    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 SponsorGador S.A.
    B.1.3.4CountryArgentina
    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 supportGador S.A.
    B.4.2CountryArgentina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEijkman & Kuipers HealthCare B.V.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressDe Pinckart 54
    B.5.3.2Town/ cityNuenen
    B.5.3.3Post code5674 CC
    B.5.3.4CountryNetherlands
    B.5.6E-mailinfo@eijkman-kuipers.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.3.1Product nameMono Sodium Olpadronate
    D.3.2Product code IG-8801
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLPADRONIC ACID
    D.3.9.1CAS number 63132-39-8
    D.3.9.2Current sponsor codeIG-8801
    D.3.9.4EV Substance CodeSUB09432MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-specific Chronic Low Back Pain persisting for at least 3 months
    E.1.1.1Medical condition in easily understood language
    Low back pain lasting for more than 3 months in the absence of neurological, oncological or autoimmune causes.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10008837
    E.1.2Term Chronic back pain
    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
    The primary objective is to assess the efficacy of intravenous IG-8801, 20 mg and 40 mg, compared to placebo, in decreasing the average pain intensity from baseline (BSL) to Week 24.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - To assess the safety and tolerability of 2 doses of IG-8801
    - To assess change from baseline of a selection of items of the Brief Pain Inventory Questionnaire:
    - Worst Pain Intensity (question 3) at Week 4, 8, 12 and 24
    - Average Pain Intensity (question 5) at Week 4, 8 and 12
    - To assess the proportion of subjects who are classified as responders at Week 4, 8, 12 and 24.
    - To assess the use of ‘rescue’ medications
    - To assess the effect of IG-8801 on the Roland Disability Questionnaire
    - To assess the subjects’ overall impression of change after study treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent must be given before any assessment is performed
    - Men or women of 21 years of age or older
    - Axial spine back pain persisting for at least three months
    - MRI evidence of disc degeneration and/or any imaging evidence of vertebral changes consistent with the diagnosis of degenerative disc disease, spondylotic disease of the lumbar spine or an old vertebral fracture
    - A Baseline Average Pain Intensity of 4 or higher. [subjects will rate their daily average pain intensity, on a scale from 0-10, and enter their response into an electronic diary. Baseline Average Pain Intensity (BSL-API) is calculated from daily average pain intensity scores obtained from electronic diary entries during the 7 days prior to the first infusion at BSL]. Subjects have to fill in the electronic diary correctly 4 days out of 7 as a minimum.
    - Subjects who are – in the opinion of the investigator – able to understand all study procedures and willing to comply with all study requirements.
    E.4Principal exclusion criteria
    - A history of prior back surgery
    - A documented clinical vertebral fracture within 6 months of study entry
    - A history of cancer in the past 5 years, except for non-melanoma skin cancer that has been treated with no evidence of recurrence in the past 3 months
    - carcinoma in situ of the cervix
    - colon polyps with non-invasive malignancy that have been removed
    - A history of hypocalcaemia
    - 25-hydroxy Vit D levels < 30 nmol/L (12.5 ng/ml).
    - An estimated glomerular filtration rate (GFR) less than 35 ml/min
    - Current clinically significant cardiac, haematological, hepatic, endocrine (e.g. primary hyperparathyroidism, uncontrolled hyper- or hypothyroidism), psychiatric (severe depression), or neurological disease
    - Diagnosed metabolic bone disease such as Paget’s disease and Osteogenesis Imperfecta. However, osteoporosis is NOT an exclusion criterion.
    - Any prior use of intravenous bisphosphonates or oral bisphosphonates in the last 3 years. Any prior use of any other antiresorptives is NOT an exclusion criterion.
    - A known allergy to bisphosphonates
    - Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable
    - A present history of alcohol abuse
    - BDI score of 29 or more
    - Subjects have had a tooth extraction or any invasive dental procedure within three months prior to study enrolment; have poor oral hygiene or inadequate dental care in the opinion of the investigator
    - Subjects who have received systemic glucocorticoid therapy within 3 months of enrolment in the study

    No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the change in daily average pain intensity score obtained from electronic diary entries during 7 days prior to the visit at baseline (BSL-API) and 24 weeks (V7-API) or at the moment of early study discontinuation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    - The change from baseline in daily average pain intensity score obtained from electronic diary entries during 7 days prior to the visit at baseline (BSL-API) at visits/call at Week 4, 8 and 12 (V5-API, Tele 2-API, V6-API)
    - The change from baseline in daily worst pain intensity score obtained from electronic diary entries during 7 days prior to the visit at baseline (BSL-WPI) at time points Week 4, 8, 12 and 24 (V5-WPI, Tele 2-WPI, V6-WPI and V7-WPI)
    - Safety parameters will be obtained via adverse events and laboratory evaluations. Tolerability will be assessed by infusion site reactions.
    - A responder assessment. Response is defined as a decrease from baseline in the daily average pain score obtained from electronic diary entries during 7 days prior to the visit (BSL-API), by at least 30% or at least 2 points on the BPI pain scale). Responder rates (proportions of responders) will be calculated for each treatment group at Week 4, 8, 12 and 24. (V5-API, Tele 2-API, V6-API and V7-API).
    - The use of “rescue medication” will be recorded by the subjects via their input into their electronic diary.
    - Effect of IG-8801 on the outcome of Roland Disability Questionnaire. This Questionnaire will be filled by the subject at V2 and V7. This patient outcome tool consists of 24 questions specifically developed to assess the severity of back pain and the associated disability. This questionnaire has been translated into Dutch and has been fully validated.
    - Effect of study treatment on subjects’ overall impression of change after study treatment via Clinical Global Impression rating scale (CGI) at V7.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 4,8,12 and 24
    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 Yes
    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.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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 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
    LVLS at 24 weeks after randomization at Day 1
    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 months6
    E.8.9.1In the Member State concerned days
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state57
    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 Care
    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 Decision2016-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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