EUCTR2015-004269-96-NL进行中（未招募）不适用
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
Gador S.A.0 个研究点开始时间: 2016年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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.
研究者
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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 paidegenerative afwijkingen van de lumbale wervelkolom leidend tot axiale aspecifieke en chronische lage rugpijnaspecific low back painchronic low back painNL-OMON46893Gador S.A.58
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