Explorative, randomized, double-blind, placebo-controlled, 3-way cross-over study to assess the effects of oral cannabidiol 160 and 1500 mg in healthy male subjects on evoked pain tests and CNS using PainCart and NeuroCart test batteries. - Cannabidiol, PainCart & NeuroCart

Centre for Human Drug Research0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 2 期
状态: 撤回
发起方: Centre for Human Drug Research
入组人数: 12

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

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Signed informed consent prior to any study-mandated procedure.
•2. Healthy male subjects, 18 up and to 55 years of age, inclusive at screening.
•3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
•with a minimum weight of 50 kg.
•4. All subjects must practice effective contraception during the study and be
•willing and able to continue contraception for at least 90 days after their
•last dose of study treatment.
•5. Has the ability to communicate well with the investigator in the Dutch
•language and willing to comply with the study restrictions.

排除标准

•1. Evidence of any active or chronic disease or condition that could interfere
•with, or for which the treatment of might interfere with, the conduct of the
•study, or that would pose an unacceptable risk to the subject in the opinion of
•the investigator (following a detailed medical history, physical examination,
•vital signs (systolic and diastolic blood pressure, pulse rate, body
•temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the
•normal range may be accepted, if judged by the investigator to have no clinical
•2. Clinically significant abnormalities, as judged by the investigator, in
•laboratory test results (including hepatic and renal panels, complete blood
•count, chemistry panel and urinalysis). In the case of uncertain or
•questionable results, tests performed during screening may be repeated before
•randomization to confirm eligibility or judged to be clinically irrelevant for
•healthy subjects.
•3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
•or human immunodeficiency virus antibody (HIV Ab) at screening.
•4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and
•diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at
•5. Abnormal relevant findings in the resting ECG at screening.
•6. Participation in an investigational drug or device study (last dosing of
•previous study was within 90 days prior to first dosing of this study).
•7. History of abuse of addictive substances (alcohol, illegal substances) or
•current use of more than 21 units alcohol per week, drug abuse, or regular user
•of sedatives, hypnotics, tranquilizers, or any other addictive agent
•8. Positive test for drugs of abuse at screening.
•9. Alcohol will not be allowed from at least 24 hours before screening or
•10. Smoker of more than 10 cigarettes per day prior to screening or who use
•tobacco products equivalent to more than 10 cigarettes per day and unable to
•abstain from smoking whilst in the unit.
•11. Excessive caffeine consumption (more than eight cups of coffee or
•equivalent per day
•12. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
•against any drug, multiple drug allergies (non-active hay fever is acceptable).
•13. Loss or donation of blood over 500 mL within three months prior to
•screening or intention to donate blood or blood products during the study.
•14. Any known factor, condition, or disease that might interfere with treatment
•compliance, study conduct or interpretation of the results such as drug or
•alcohol dependence or psychiatric disease.
•15. Any current, clinically significant, known medical condition in particular
•any existing conditions that would affect sensitivity to cold (such as
•atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (disease
•that causes pain, hypesthesia, hyperalgesia, allodynia, paresthesia,
•neuropathy, etc.).
•16. Subjects indicating pain tests intolerable at screening or achieving
•tolerance at >80% of maximum input intensity for the cold, pressure and
•electrical tests.
•17. Subject indicating intolerable pain after capsaicin administration at
•18. History or presence of post-inflammatory hyperpigmentation.
•19. Dark skin (Fitzpatrick skin type IV, V or VI), widespread acne, freckles

研究者

发起方

Centre for Human Drug Research

相似试验

进行中（未招募）

1 期

Study to assess the effects of oral cannabidiol in healthy male subjects on CNS using the NeuroCart test battery and TMS.eurological assessments

CTIS2023-508311-23-00Centre for Human Drug Research24

进行中（未招募）

1 期

A clinical trial to find out whether GRT6010, when instilled into the bladder, eases pain and functional symptoms, is safe, and is tolerable in adults with bladder pain syndrome

EUCTR2016-003940-35-PLGrünenthal GmbH120

进行中（未招募）

1 期

A clinical trial to find out whether GRT6010, when instilled into the bladder, eases pain and functional symptoms, is safe, and is tolerable in adults with bladder pain syndromeBladder pain syndrome.MedDRA version: 19.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857

EUCTR2016-003940-35-DEGrünenthal GmbH120

进行中（未招募）

不适用

EUCTR2009-011931-11-DEAlmirall Hermal GmbH180

进行中（未招募）

1 期

Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colon surgery.Postoperative pain after colon rectal cancer surgery are mainly intended to relieve as well resting as activity-induced pain. Secondarily, the choice of pain management should take into consideration how to ensure the earliest possible mobilization and rapid fluid and food intake. There are now some evidence in laparoscopic gastrointestinal surgery that supports that perioperative infusion of lidocaine intravenously can reduce opioid consumption and length of postoperative ileus.MedDRA version: 17.1Level: LLTClassification code 10018017Term: Gastrointestinal tract cancer NOSSystem Organ Class: 100000004864

EUCTR2014-003466-25-DKAnders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital