JPRN-jRCT2051220144招募中1 期
Phase I/II trial for safety and pharmacokinetics of ENDOPIN in healthy adults and patients with postoperative pain
akajima Takako0 个研究点目标入组 46 人开始时间: 2023年1月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Phase 1 Part
- •1) Male age between 18 and 40 years old at the time consent is obtained.
- •2) 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
- •3) Non-smoker and no history of smoking in the past year
- •4) Written consent to participate in this study has been obtained from the individual.
- •Phase 2 Part
- •1) Patients must be at least 18 years of age at the time of consent.
- •2) Patients who have undergone thoracoscopic lobectomy or segmentectomy for primary lung cancer within 8 weeks of obtaining consent.
- •3) Patients must have the following on the most recent examination within 56 days prior to enrollment
- •HbA1c (NGSP value) less than 7.0 %.
- •4) 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.
- •5) Written consent to participate in this study has been obtained from the patient.
- •6) 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
- •1) 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
- •2) Positive infectious disease test at screening: HBs antigen/antibody, HBc antibody, HCV antibody, HIV antigen/antibody, syphilis, tuberculosis
- •3) Positive PCR test for novel coronavirus at the time of admission
- •4) Those diagnosed with infectious gastroenteritis within 7 days prior to enrollment (including family members living in the same household)
- •5) Has food allergy or drug hypersensitivity or has a history of such allergy or drug hypersensitivity.
- •6) Has alcohol or drug dependence or a history of alcohol or drug dependence.
- •7) Has used systemic drugs as a regular prescription within 4 weeks prior to obtaining consent.
- •8) Participates in another clinical study or trial involving an intervention within 4 months (same date 4 months prior) prior to obtaining consent.
- •9) Cannot agree to use contraception for a period of up to 7 days after administration of the investigational drug.
- •10) Uses oral medications other than investigational drugs and topical medications containing analgesic ingredients within 7 days prior to enrollment.
- •11) 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.
- •12) Have previously received the investigational drug.
- •13) Other patients who, in the judgment of the investigator or subinvestigator, are inappropriate to participate in this clinical trial.
- •Phase 2 Part
- •1) 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
- •2) Use of analgesics (oral or topical) as a regular prescription within 4 weeks prior to obtaining consent.
- •3) Participating in another clinical study/trial involving intervention within 4 months (same date 4 months prior) prior to obtaining consent.
- •4) Has a history of hypersensitivity to loxoprofen sodium hydrate, acetaminophen and local anesthetics, clonidine hydrochloride tablets, guanabenz acetate tablets, methyldopa tablets, dexmedetomidine.
- •5) Has undergone another surgical procedure within 4 weeks prior to obtaining consent.
- •6) Unable to consent to smoking cessation up to 1 month prior to administration of the investigational drug (same date 1 month prior).
- •7) Male who cannot agree to use contraception up to 7 days after administration of the investigational drug.
- •8) Other subjects who, in the judgment of the investigator or subinvestigator, are considered inappropriate to participate in this clinical trial.
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