DRKS00000183已完成3 期
Double-blind, randomised, placebo-controlled prospective multicenter phase III trial to assess the efficacy and safety of topical propyl nicotinate (Elacur® hot) in adjuvant treatment of chronic non-specific low back pain
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 461
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. caucasian origin
- •2. chronic non-specific low back pain (lumbar region): subjective back pain of at least 40 mm but not more than 80 mm on a 100 mm long Visual Analogue Scale (VAS).
- •3. duration of low back pain for at least 3 months
- •4. no history of drug- and alcohol abuse
- •5. no current or previous participation in another clinical trial in the last 4 weeks
- •6. concurrent therapy which could interact with the study medication had to be discontinued at appropriate periods before enrollment:
- •the evening before treatment: physical treatment
- •30h before treatment: Paracetamol
- •7 days before treatment: Topical medication, muscle relaxants, dose change or start of antihistamines. NSAIDs
- •8 days before treatment: for Sulindac, Azapropazon, Etoricoxib, Meloxicam, Oxyphenbutazon
- •17 days before entry: Piroxicam
- •30 days before treatment for Tenoxicam, Phenylbutazon.
- •four weeks before treatment: systemic opiates and their derivatives, surgical procedures or nerve blocks in the treatment area, treatment with anti-depressants, anxiolytics or sedatives
- •eight weeks before treatment: parenteral corticosteroids, oral corticosteroids equivalent to > 10mg/day prednisolon.
- •7. female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, sponge, spermicide, contraceptive implants, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential i.e. menopause, had hysterectomy, bilateral ovariectomy, tubal ligation or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status
- •8. written informed consent given by patient after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
- •9. no legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
排除标准
- •. concomitant medication or procedures which would interfere with trial medication
- •2. known hypersensitivity to ingredients
- •3. all forms of specific back pain (attributable to a defined basic illness i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractions, infections and inflammatory disorders, cervical spine syndrome, osteoporosis, rheumatoid arthritis, Lyme?s arthritis, known chronic skin disease
- •4. Untreated and uncontrolled hypertension
- •5. Concomitant systemic inflammatory rheumatic condition
- •6. known contraindication for study medication
- •7. pregnancy or lactation in female patients
- •8. unreliability and/ or lack of cooperation
- •9. other objections to participate in the study in the opinion of the investigator
研究者
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