EUCTR2012-000730-19-NL进行中（未招募）1 期
The analgesic efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design - Delta-Pain II
Radboud University Nijmegen Medical Centre0 个研究点目标入组 68 人开始时间: 2012年3月12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
- 68
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
- •Aged 18 years or older
- •Confirmed chronic pancreatitis
- •Pain duration exceeding 3 months, and average NRS=3
- •Stable doses intake of analgesics for the past 2 months
- •The patient has been informed about the study, understood the information and signed the informed consent form
- •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 68
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient took cannabinoids on a regular basis for at least one year
- •Patient does not feel a pinprick test in the lower extremities
- •Patient has a body mass index (BMI) above 32,0 kg/m2
- •Patient suffers from serious painful conditions other than chronic pancreatitis
- •Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
- •Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
- •Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
- •Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
- •Patient has an actual moderate to severe renal impairment
- •Patient has an actual moderate to severe hepatic impairment
- •Patient has a presence or history of major psychiatric illness
- •Patient has experienced an epileptic seizure in the past
- •Patient demonstrates clinically significant laboratory abnormalities
- •Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
- •Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
- •Patient has a history of sensitivity / idiosyncrasy to THC
- •Patient has a known or suspected lactose intolerance
- •Female patient is pregnant or breastfeeding
- •Patient intends to conceive a child during the course of the study
- •Patient participates in another investigational drug study
- •Patient has a clinical significant exacerbation in illness
- •Patient is unwilling or unable to comply with the lifestyle guidelines
研究者
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