A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of visual analogue scale
研究概览
简要总结
To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement.
详细描述
Randomized, double-blind, parallel-group, 3-arm, oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
The complete evaluable 36 subjects (12 subjects in each group) will be analysis in this study. The experiment is divided into three groups of 12 people each. All subjects will be evaluated pharmacokinetics by drawing blood single point at 70.75 ± 2 hours after the first dose..
The population for this study in patients scheduled for knee replacement.
Each group of 12 subjects are administered group 1-3 from day 1-4 after surgery. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose. Mode of administration of oral Naldebain 37.5 mg (0.5 mL oil solution) or Placebo B (0.5 mL oil solution) is withdrawing 0.5 mL of Naldebain 37.5 mg (0.5 mL oil solution) or Placebo B (0.5 mL oil solution) from the vial by a syringe, then is injected into the empty capsule and dispense within 10 minutes prior to dosing.
Screening (Days -30 to -1) (All Study Subjects)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≧ 20 years of age at Screening.
- •Knee replacement patients.
- •American Society of Anesthesiology Physical Class 1 and
- •Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
排除标准
- •Body weight less than 50 kg.
- •Subject is pregnant or breastfeeding. Women of childbearing potential have a positive urine pregnancy test at baseline.
- •Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
- •History of hypersensitivity or allergy to amide-type local anesthetics, opioid, acetaminophen, or any ingredient of the medications administered in this study.
- •Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 %.
- •Administration of an investigational drug within 5 elimination half-lives of such investigational drug prior to study drug administration.
- •The investigator judged that any psychiatric disorder or psychological condition that may interfere with study assessments or compliance.
- •History of abuse illicit medications, prescription medicines or alcohol within the past 2 years. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120 mL wine or 14 cans of 350 mL beer).
- •Current painful physical condition other than knee pain.
- •The investigator judged that the sensory nerve examination results were abnormal before the knee replacement in this trial.
研究组 & 干预措施
Naldebain
Oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
干预措施: Naldebain (Drug)
SafeTynadol
Oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) +Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.
干预措施: SafeTynadol (Drug)
Naldebain + SafeTynadol
Oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 25 hours after the first dose.
干预措施: Naldebain + SafeTynadol (Drug)
结局指标
主要结局
Area under the curve (AUC) of visual analogue scale
时间窗: 0 hour - 70 hours after first dose
Pain assessment calculated as the area under the curve (AUC) of visual analogue scale (VAS, 0-100 mm) pain intensity scores through 70 ± 2 hours after the first dose.
次要结局
- Assessment of ALT and AST(Day 4)
- The first time using any one kind of rescue medication(Day 1 - Day 4)
- The evaluation of adverse events(Day 1 - Day 6)
- Patient satisfaction(Day 4)
- Consumption of rescued parecoxib(Day 1 - Day 4)
- Brief Pain Inventory short form (BPIsf)(Day 2 - Day 4)