EUCTR2012-005808-17-NL进行中（未招募）1 期
The analgesic efficacy of perioperative ?9-THC (Namisol®) in patients undergoing major abdominal surgery: a randomized, double blinded, placebo-controlled, parallel design - NamiSur
Radboud University Medical Centre0 个研究点目标入组 40 人开始时间: 2013年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient is between 18 and on the day the informed consent form will be signed.
- •2.Patient has persistent or intermittent abdominal pain, due to underlying pathology including diverticulitis, m. Crohn, ulcerative colitis, endometriosis, or abdominal adhesions. Other pathology may be included if so judged by the investigator.
- •3.Patient is undergoing elective, open abdominal surgery with planned use of an epidural catheter the surgical procedure has an estimated duration of at least two hours, not including the time to induce anesthesia.
- •4.Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
- •5.Patient has a stable medication regimen of analgesics for at least 2 weeks prior to study entry.
- •6.Patient is willing and able to comply with the lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other trial procedures.
- •7.Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient is diagnosed with chronic pancreatitis, ACNES, abdominal hernia, inguinal hernia, abdominal wall pathology or intestinal fistula.
- •2.Patient suffers from persistent or intermittent abdominal pain (on a daily basis in at least 3 months) with average NRS = 3, based or probably based on past abdominal surgery or other causes for the pain, for example, continuing malignancy, chronic infection or from diabetes mellitus.
- •3.Patient has an unstable regimen of analgesics or a regimen of analgesics which includes tricyclic antidepressants or ?2-?-binding Ca++ channel blockers such as gabapentin.
- •4.Patient is ineligible for the anesthesia protocol, as judged by the investigator.
- •5.Patient is admitted to the hospital on the day of surgery itself
- •6.Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one month on the day of screening.
- •7.Patient has a (history of) a malignant or other significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient, including terminal illness.
- •8.Patient uses concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals).
- •9.Patient does not tolerate oral intake of food/liquids or is refrained from oral intake because of medical reasons.
- •10.Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG) parameters at screening.
- •11.Patient is at the moment of screening diagnosed with moderate to severe renal impairment as judged by the investigator.
- •12.Patient is at the moment of screening diagnosed with moderate to severe hepatic failure as judged by the investigator.
- •13.Patient has a presence or history of major psychiatric illness as judged by the investigator, e.g. major depression, schizophrenia.
- •14.Patient demonstrates clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •15.Patient has a known history of alcohol or substance abuse.
- •16.Patient has a history of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or to any other related drug used in the past.
- •17.Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine, MDMA, and amphetamines.
- •18.Female patient is pregnant (childbearing potential must have a negative pregnancy test prior to each study day) or breastfeeding during the course of the study.
- •19.Female childbearing potential has to use acceptable birth control measures including oral contraceptives, intrauterine devices or mechanical methods.
- •20.Patient intends to conceive a child during the course of the study.
- •21.Patient participates in another investigational drug study within 90 days prior to the first dose and/or participates in more than 2 clinical trials in the last year.
- •22.Patient has a clinical significant exacerbation in illness within two weeks of participating in this study.
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