The safety, tolerability, and analgesic efficacy of ?9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain - ?9-THC in chronic pain

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2011年5月12日最近更新: 2013年7月29日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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: Male

入选标准

•1.Patient is 18 years or older on the day the informed consent form will be signed.
•2.Patient is male.
•3.Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
•4.Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (intermittent or persistent pain on a daily basis in at least 3 months), and must consider their pain as severe enough for medical treatment (average NRS = 3).
•5.Patient in de opioid subgroup takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the investigator.
•6.Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.
•7.Patient is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
•8.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: 24
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1.Patient did not took any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
•2.Patient is insulin depended for more than 5 years on the day of screening.
•3.Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
•4.Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
•BMI (kg/m²) = weight (kg) / (height * height) (m2)
•5.Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
•6.Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
•7.Patient uses any kind of 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 or proton-pump inhibitors).
•8.Patient takes drip-feed.
•9.Patient takes amitriptyline on a daily base and is unable/unwilling to refrain from amitriptyline from 24 hours before each study day.
•10.Patient demonstrates deviating ECG parameters at screening, e.g. heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
•11.Patient is previously diagnosed with moderate to severe renal impairment, e.g. creatinine values > 2x ULN and/or a significant change of their normal values.
•12.Patient is previously diagnosed with moderate to severe hepatic failure or show significant clinical abnormalities in biochemistry blood sample.
•13.Patient has a presence or history of major psychiatric illness as judged by 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 history of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or to any other related drug used in the past.
•16.Patient shows a positive alcohol breath test at screening or admission and/or is unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn.
•17.Patient demonstrates a positive urine screen at screening visit for THC, cocaine, MDMA, and amphetamines.
•18.Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test.
•19.Patient is unwilling or unable to comply with the lifestyle guidelines.
•20.Patients intends to father 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.

研究者

发起方

Radboud University Nijmegen Medical Centre

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