A Phase 3 Study of JNS013 in Patients With Chronic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 主要终点
- Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
详细描述
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
- •Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
- •Outpatients
- •Ambulatory participants without need for any supportive device or assistance during daily life
排除标准
- •Participants with conditions for which opioids are contraindicated
- •Participants with conditions for which acetaminophen is contraindicated
- •Participants with history of convulsion or the possibility of convulsive seizure
- •Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
- •Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
研究组 & 干预措施
Placebo (Double-Blind)
干预措施: Placebo (Double-Blind) (Drug)
Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
干预措施: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) (Drug)
Tramadol Hydrochloride Plus Acetaminophen (Double Blind)
干预措施: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) (Drug)
结局指标
主要结局
Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
时间窗: Day 28 of double-blind period
The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 \[VAS24\] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.
次要结局
- Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period(Day 1 of open-label period and Day 1 of double-blind period)
- Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period(Day 1 and Day 28 of double-blind period)
- Mean Pain Relief (PAR) Score During the Open-Label Period(2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period)
- Mean Pain Intensity (PI) Score During Open-Label Period(Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period)
- Mean PI Score During Double-Blind Period(Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period)
- Mean Pain Intensity Difference (PID) During the Open-Label Period(Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period)
- Mean PID During the Double-Blind Period(Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period)
- Mean PAR Score During the Double-Blind Period(2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period)
- Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period(2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period)
- Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period(2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period)
- Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period(Day 1, and Day 8 of open-label period)
- Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period(Day 1, 8, 15, 22 and 28 of double-blind period)
- Total Pain Relief (TOTPAR) Score During the Open-Label Period(Day 1 and Day 8 of open-label period)
- Total Pain Relief (TOTPAR) Score During the Double-Blind Period(Day 1, 8, 15, 22 and 28 of double-blind period)
- Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period(Day 1, and Day 8 of open-label period)
- Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period(Day 1, 8, 15, 22 and 28 of double-blind period)
- Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period(Day 1 and Day 14 of open-label period)
- Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period(Day 1 and Day 28 of double-blind period)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period(Day 1 and Day 14 of open-label period)
- Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period(Day 1 and Day 28 of double-blind period)
- Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period(Day 1 and Day 14 of open-label period)
- Change From Baseline in SF-36 at Day 28 of Double-Blind Period(Day 1 and Day 28 of double-blind period)