non-specific Chronic Low Back Pain persisting for at least 3 months MedDRA version: 18.1 Level: LLT Classification code 10008837 Term: Chronic back pain System Organ Class: 100000004859
Conditions
Interventions
Product Name: Mono Sodium Olpadronate
Product Code: IG-8801
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OLPADRONIC ACID
CAS Number: 63132-39-8
Current Sponsor code: IG-8801
Concent
Sponsors
Gador S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Primary 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. ;Secondary Objective: 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 ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and Week 4,8,12 and 24;Secondary 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. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Information
Eijkman & Kuipers HealthCare B.V.
Outcome results
None listed