EUCTR2014-003040-12-IT进行中（未招募）1 期
A phase III, multicenter, randomized, parallel groups study to assess the efficacy and safety of 0,5 mg Tizaspray® administered intranasally versus Sirdalud® 2 mg tablets, in patients with acute low back pain
MDM S.p.A.0 个研究点目标入组 236 人开始时间: 2014年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 236
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
- •1. Age between 18 and 65 years old
- •2. Average low back pain intensity moderate to severe (= 60 mm in the VAS) at Visit 1
- •3. Positivity to Schober test (i.e. measure < 5 cm) at Visit 1
- •4. Acute low back pain started at least 48 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
- •5. Negative pregnancy test for women of childbearing potential (to be performed at Visit 1) and use of an acceptable mean of contraception (condom or mechanical methods) in the previous 2 months and for whole duration of the study
- •6. Signed Informed Consent
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. History of chronic low back pain
- •2. Current treatment with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
- •3. Current treatment with any other muscle relaxant or any drugs having muscle relaxant properties
- •4. Known allergies, hypersensitivity, or intolerance to tizanidine or paracetamol or any excipients used in their manufacture (included patients with known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
- •5. Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
- •6. Evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study
- •7. Spinal surgery within 1 year of study entry
- •8. Evidence of clinical gastrointestinal malabsorption
- •9. Use of steroids within 3 months of study entry or any other long-term treatment with steroids
- •10. Use of NSAID’s or other anti-inflammatory drugs 6 hours prior to study inclusion
- •11. Use of fluvoxamine or ciprofloxacin, or other inhibitors of CYP1A2 such as antiarrhythmics (amiodarone, mexiletine, propafenone), cimetidine, fluoroquinolones (enoxacin, pefloxacin, norfloxacin), rofecoxib, oral contraceptives, and ticlopidine
- •12. Use of hypnotics or other CNS depressants
- •13. Blood pressure <100/70 mmHg and/or treated with antihypertensive drug
- •14. History of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
- •15. Severe scoliosis
- •16. More severe pain in a region other than the lower back
- •17. Acute low back pain associated with chills or fever
- •18. Pregnancy, breast feeding
- •19. Treatment with another investigational agent within the last 30 days
- •20.Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment
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