NCT00952068已完成2 期
A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Time to Onset of Perceptible Pain Relief
研究概览
简要总结
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in generally good health aged 18-80 years with acute low back pain are eligible for this study.
- •Patients must have pain of moderate to severe intensity on the patient rating of pain intensity scale without analgesia.
- •Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- •Must have signed and dated an REB-approved written Informed Consent form which was also signed and dated by the Investigator prior to study participation.
排除标准
- •Known history or symptoms suspicious of:
- •Spinal fracture
- •Cancer (i.e. constitutional symptoms such as recent unexplained chills or weight loss)
- •Spinal infection (e.g. IV drug abuse, immunosuppression)
- •Cauda equina syndrome
- •Spina bifida
- •Foot drop
- •Spinal surgery within 1 year of study entry
- •Body Mass Index (BMI) > 37
- •Continuous chronic back pain
- •More severe pain in a region other than the lower back
- •Treatment of the back pain with non-pharmacological therapy (e.g. acupuncture chiropractic adjustment, Transcutaneous Electrical Nerve Stimulation, physiotherapy etc.) in the 3 weeks prior to study entry
- •Use of any sedative hypnotics, topical preparations/medications and anaesthetics or muscle relaxants within 5 half-lives of the dose of study medication
- •Use of any analgesic within 6 hours of the dose of study medication. In rare cases, if a patient is in moderate to severe pain despite having taken a short-acting analgesic and if at least 2 hours have passed since the dose of short-acting analgesic, the patient may be entered.
- •A major illness, requiring hospitalisation during the 3 months before commencement of the screening period
- •Unwillingness to stop taking pain medication other than the study medication
- •Previous failure of treatment with tramadol or discontinuation of treatment with tramadol due to adverse events
- •Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors (SSRIs); serotonin-norepinephrine reuptake inhibitors (SNRIs) or any other drug that reduces seizure threshold
- •Treatment with another investigational agent within the last 30 days
- •History of seizure disorder other than Infantile Febrile Seizures
- •Previous or current opioid dependency
- •Bowel disease causing malabsorption
- •Pregnant or lactating women
- •Known significant liver disease or symptoms of significant liver disease
- •Known significant renal disease or symptoms of significant renal disease
- •Current or past substance abuse or dependence, other than nicotine
- •Allergy to tramadol or any structurally similar drugs (e.g. opiates)
- •Any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures
研究组 & 干预措施
Tramadol Contramid® OAD 200mg
Experimental
1 Tramadol Contramid® OAD 200mg tablet daily.
干预措施: Tramadol Contramid® OAD 200mg (Drug)
结局指标
主要结局
Time to Onset of Perceptible Pain Relief
时间窗: 6 hours
Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.
次要结局
- Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose(Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief)
- Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose(3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief)
- Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose(Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose)
- Number of Participants With Adverse Events(6 hours)
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