A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 主要终点
- Total Pain Relief Based on Numerical Rating Scale (NRS) Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.
详细描述
This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants planned to receive a tooth extraction of one mandibular impacted wisdom tooth
- •Participants who require bone removal and separation of the crown at tooth extraction
- •Participants whose intensity of pain associated with tooth extraction within 2 hours after tooth extraction is greater than or equal to 50.0 millimeter on the visual analog scale (VAS)
- •Participants who did not undergo general anesthesia or sedation at tooth extraction
- •Participants without an abnormality (including laboratory test values) corresponding to Grade 3 in the "Criteria for severity classification of adverse drug reactions" during the pretreatment observation period
排除标准
- •Participants with conditions for which tramadol is contraindicated
- •Participants with conditions for which acetaminophen is contraindicated
- •Participants with history of convulsions or the possibility of convulsive seizures
- •Pregnant participants or those who may be pregnant, lactating mothers, and those who wish pregnancy during the study period
- •Participants with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction
研究组 & 干预措施
Tramadol plus Acetaminophen and Placebo
Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Placebo (Drug)
Tramadol plus Acetaminophen and Placebo
Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Tramadol plus Acetaminophen (Drug)
Tramadol and Placebo
Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Tramadol Hydrochloride (Drug)
Tramadol and Placebo
Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Placebo (Drug)
Acetaminophen and Placebo
Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Acetaminophen (Drug)
Acetaminophen and Placebo
Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
干预措施: Placebo (Drug)
结局指标
主要结局
Total Pain Relief Based on Numerical Rating Scale (NRS) Score
时间窗: 8 hours
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
次要结局
- Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours(Baseline up to 8 hours post-administration of study treatment)
- Sum of Pain Intensity Difference (SPID)(Baseline up to 8 hours post-administration of study treatment)
- Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)(Baseline up to 8 hours post-administration of study treatment)
- Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment(0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment)
- Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment(0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment)
- Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment(0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment)
- Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment(0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment)
- Number of Participants Treated With a Relief Analgesic(Baseline up to 8 hours post-administration of study treatment)
- Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain(Baseline up to 8 hours post-administration of study treatment)
- Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy(Baseline up to 8 hours post-administration of study treatment)
- Percentage of Participants With Categorical Score for Patient Impressions(Baseline up to 8 hours post-administration of study treatment)