The Clinical Efficacy and Safety Study of Tramadol Hydrochloride - Paracetamol Tablets in the Treatment of Moderate to Severe Acute Neck-shoulder Pain and Low Back Pain in Orthopaedics Outpatient or Emergency Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,059
- 主要终点
- Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.
详细描述
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent or persistent pain for less than 3 months, required analgesic therapy, orthopedic surgery and emergency call participants suffering with severe neck, shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and severe form of illness in its early stage) exacerbation pain
- •Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)
- •During normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary
- •Be willing to participate in the study and must give written informed consent
排除标准
- •Have used strong opium kind of medication 7 days prior to the enrolment
- •Have severe mental disease or using antipsychotic (agent that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) medication for medical treatment
- •Drug abuse/dependence, or chronic alcohol abuse/depend on history
- •Pregnant or lactating women
- •Unable to tolerate tramadol or any failed treatment in past by using tramadol
- •Comparatively more severe pain in other parts of the body than that of the pain mentioned in the research
研究组 & 干预措施
Tramadol Hydrochloride (HCl)-Paracetamol
干预措施: Tramadol HCl-Paracetamol (Drug)
结局指标
主要结局
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
时间窗: Hour 0.5
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
时间窗: Hour 1
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
时间窗: Hour 2
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
时间窗: Hour 3
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
时间窗: Hour 4
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
时间窗: Hour 6
Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Number of Participants With Pain Relief Score at Hour 0.5
时间窗: Hour 0.5
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 1
时间窗: Hour 1
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 2
时间窗: Hour 2
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 3
时间窗: Hour 3
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 4
时间窗: Hour 4
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 6
时间窗: Hour 6
Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
次要结局
- Number of Participants Who Required Additional Dosage Administration(Baseline up to Hour 2)
- Number of Participants With Analgesic Satisfaction Score(Hour 6)
- Number of Participants With Overall Analgesic Satisfaction Score(Hour 6)