jRCT2051220144进行中（未招募）不适用
Phase I/II trial for safety and pharmacokinetics of ENDOPIN in healthy adults and patients with postoperative pain
未提供0 个研究点目标入组 46 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Phase 1 Part
- •Male age between 18 and 40 years old at the time consent is obtained.
- •All of the following are met at the pre-enrollment examination
- •Hemoglobin level more than or equal to 10 g/dL
- •White blood cell count more than or equal to 3,000 /micro-L
- •Platelet count more than or equal to 100,000/micro-L
- •AST (GOT) less than or equal to 50 U/L
- •ALT (GPT) less than or equal to 50 U/L
- •Total bilirubin less than or equal to1.5 mg/dL
- •Serum creatinine less than or equal to 1.5 mg/dL
- •HbA1c (NGSP) less than 7.0 % (data within 56 days prior to enrollment are acceptable)
- •BMI more than or equal to 18.5 and less than 25.0
- •Non-smoker and no history of smoking in the past year
- •Written consent to participate in this study has been obtained from the individual.
- •Phase 2 Part
- •Patients must be at least 18 years of age at the time of consent.
- •Patients who have undergone thoracoscopic lobectomy or segmentectomy for primary lung cancer within 8 weeks of obtaining consent.
- •Patients must have the following on the most recent examination within 56 days prior to enrollment
- •HbA1c (NGSP value) less than 7.0 %.
- •For female patients, one of the following is met and there is no possibility of pregnancy
- •The patient has been considered menopausal for at least 12 months since her last menstrual period without another medical reason.
- •Has undergone permanent sterilization such as bilateral oophorectomy, bilateral tubal ligation, etc.
- •Written consent to participate in this study has been obtained from the patient.
- •The following criteria are met on the first day after surgery
- •6-1) All of the following are met at the pre-registration examination on the 1st day after surgery
- •Hemoglobin level more than or equal to 10 g/dL
- •White blood cell count more than or equal to 3,000 /micro-L
- •Platelet count more than or equal to 100,000 /micro-L
- •AST (GOT) less than or equal to 50 U/L
- •ALT (GPT) less than or equal to 50 U/L
- •Total bilirubin less than or equal to 1.5 mg/dL
- •Serum creatinine less than or equal to 1.5 mg/dL
- •6-2)Systemic antipyretic analgesics are not necessary for fever
- •6-3)NRS pain scale is more than ornequal to 4 and the patient can take loxoprofen sodium tablets 60 mg
- •6-4) No serious complications (pneumonia, respiratory failure, pulmonary thromboembolism, etc.) related to the surgery have developed.
排除标准
- •Phase 1 Part
- •Patient has one of the following complications
- •Serious hepatic or renal disease
- •Cardiac dysfunction equivalent to NYHA II degree or higher
- •History of malignancy or liver disease requiring treatment
- •Positive infectious disease test at screening: HBs antigen/antibody, HBc antibody, HCV antibody, HIV antigen/antibody, syphilis, tuberculosis
- •Positive PCR test for novel coronavirus at the time of admission
- •Those diagnosed with infectious gastroenteritis within 7 days prior to enrollment (including family members living in the same household)
- •Has food allergy or drug hypersensitivity or has a history of such allergy or drug hypersensitivity.
- •Has alcohol or drug dependence or a history of alcohol or drug dependence.
- •Has used systemic drugs as a regular prescription within 4 weeks prior to obtaining consent.
- •Participates in another clinical study or trial involving an intervention within 4 months (same date 4 months prior) prior to obtaining consent.
- •Cannot agree to use contraception for a period of up to 7 days after administration of the investigational drug.
- •Uses oral medications other than investigational drugs and topical medications containing analgesic ingredients within 7 days prior to enrollment.
- •Has had blood drawn or donated more than 200 mL within 4 weeks or 400 mL within 12 weeks prior to administration of the investigational drug, and has donated component blood within 2 weeks prior to administration of the investigational drug.
- •Have previously received the investigational drug.
- •Other patients who, in the judgment of the investigator or subinvestigator, are inappropriate to participate in this clinical trial.
- •Phase 2 Part
- •One of the following complications
- •Serious liver or renal disease
- •Cardiac dysfunction equivalent to NYHA II degree or higher
- •Peptic ulcer, aspirin asthma, or a history of peptic ulcer
- •Disease with pain that may affect pain assessment
- •Use of analgesics (oral or topical) as a regular prescription within 4 weeks prior to obtaining consent.
- •Participating in another clinical study/trial involving intervention within 4 months (same date 4 months prior) prior to obtaining consent.
- •Has a history of hypersensitivity to loxoprofen sodium hydrate, acetaminophen and local anesthetics, clonidine hydrochloride tablets, guanabenz acetate tablets, methyldopa tablets, dexmedetomidine.
- •Has undergone another surgical procedure within 4 weeks prior to obtaining consent.
- •Unable to consent to smoking cessation up to 1 month prior to administration of the investigational drug (same date 1 month prior).
- •Male who cannot agree to use contraception up to 7 days after administration of the investigational drug.
- •Other subjects who, in the judgment of the investigator or subinvestigator, are considered inappropriate to participate in this clinical trial.
结局指标
主要结局
-
Safety (Phase 1 part, Phase 2 part)
次要结局
- Plasma drug concentration
- Assessment of pain improvement
- Usage of rescue medication
- Evaluation of patient impressions
研究者
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