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 pai
- Conditions
- degenerative afwijkingen van de lumbale wervelkolom leidend tot axiale aspecifieke en chronische lage rugpijnaspecific low back painchronic low back pain
- Registration Number
- NL-OMON46893
- Lead Sponsor
- Gador S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
- 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.
- 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 (e.g. atrial fibrillation), hematological (e.g. anaemia), hepatic (e.g. more than 2 x the upper limit of liver enzymes), endocrine (e.g. primary hyperparathyroidism, uncontrolled hyper- or hypothyroidism), or psychiatric disease (e.g. severe depression)
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from Baseline in pain scores after 24 weeks (part of the Brief Pain<br /><br>Inventory) measured with an electronic Diary.</p><br>
- Secondary Outcome Measures
Name Time Method