NCT02934061已完成3 期
A Phase III, Multicenter, Randomized 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.1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- "hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
研究概览
简要总结
Open label, randomized, controlled, multicenter study with two parallel groups of patients
详细描述
This is a phase III, open label, randomized, controlled, multicenter study with two parallel groups of patients.
Tizaspray® 0.5 mg (a new pharmaceutical form, liquid nasal spray solution), is proposed in this trial as a ready to use treatment for short term therapy of painful muscle spasms as the acute low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old
- •Average low back pain intensity moderate to severe (≥ 60 mm in the VAS) at Visit 1
- •Positivity to Schober test (i.e. measure < 5 cm) at Visit 1
- •Acute low back pain started at least 24 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
- •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
- •Signed Informed Consent
排除标准
- •History of chronic low back pain
- •Current treatment with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
- •Current treatment with any other muscle relaxant or any drugs having muscle relaxant properties
- •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)
- •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
- •Evidence of clinically unstable disease, as determined by medical history, physical examination, that, in the Investigator's opinion, preclude entry into the study
- •Spinal surgery within 1 year of study entry
- •Evidence of clinical gastrointestinal malabsorption
- •Use of steroids within 3 months of study entry or any other long-term treatment with steroids
- •Use of NSAID's or other anti-inflammatory drugs 6 hours prior to study inclusion
- •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
- •Use of hypnotics or other CNS depressants
- •Blood pressure <100/70 mmHg
- •History of lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
- •Severe scoliosis
- •More severe pain in a region other than the lower back
- •Acute low back pain associated with chills or fever
- •Pregnancy, breast feeding
- •Treatment with another investigational agent within the last 30 days
- •Known or suspected history of alcohol or drug abuse based on medical history, physical examination, or the Investigator's clinical judgment
研究组 & 干预措施
Tizaspray®
Experimental
Tizaspray® administered intranasally in patients with acute low back pain
干预措施: Tizaspray® administered intranasally (Device)
Sirdalud®
Active Comparator
Sirdalud® 2 mg tablets administered in patients with acute low back pain
干预措施: Sirdalud® 2 mg tablets administered (Drug)
结局指标
主要结局
"hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)
时间窗: days: 1
次要结局
- "hand-to-floor" distance, Low Back Pain Intensity Scale (0 to 100 mm VAS), Schober test (positive/negative), Roland Disability Questionnaire (RDQ)(days: 8)
研究者
研究点 (1)
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