NL-OMON51174尚未招募2 期
Transvamix (10% THC / 5% CBD) to treat chronic pain in Epidermolysis Bullosa: An explorative randomized, placebo-controlled and double-blind intervention crossover study - A study on the effect of Transvamix for pain in adults with EB
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
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
- 12 至 99（—）
入选标准
- •- Clinical diagnosis, supplemented by genetic analysis, immunofluorescent
- •diagnostics or electron microscopy of congenital epidermolysis bullosa (EB).
- •Including the EB types recessive dystrophic EB, dominant dystrophic EB,
- •junctional EB and EB simplex.
- •- At least 16 years of age from the date of onset of participation.
- •- Can read and write in the Dutch language.
- •- Mentally competent and legally able to appreciate informed consent.
- •- Reporting an average pain or pruritus mean score >=4 on NRS (0-10) averaged
- •throughout the previous week at one of the following times of day: morning,
- •afternoon or evening.
- •- - Negative COVID-19 testing will be required prior to participation.
排除标准
- •- Patients enrolled in other clinical trials that do not allow for a deviation
- •in treatment.
- •- Have experienced myocardial infarction or clinically significant cardiac
- •dysfunction within the last 12 months or have had a cardiac disorder that, in
- •the opinion of the investigator would have put the participant at risk of a
- •clinically significant arrhythmia or myocardial infarction.
- •- Patients with known psychotic disorder (including the use of antipsychotic
- •medications), or a history of suicidal ideation.
- •- Female patients of child-bearing potential and male participants whose
- •partner was of child-bearing potential, unless willing to ensure that they or
- •their partner used effective contraception.
- •- Patients who have had significantly impaired renal or hepatic function in the
- •last 12 months.
- •- The patient is currently using or has used cannabis or cannabinoid-based
- •medications within 30 days of study entry and was unwilling to abstain for the
- •duration of the study.
- •- Patients unwilling or unable to refrain from driving road vehicles and/or
- •using potentially dangerous machinery where sufficient concentration is
- •- Patients unable to stay within the Netherlands for the duration of the study
- •- History of addiction and/or hospital admission due to addiction to
- •recreational or pharmaceutical drugs.
- •- Patients with contradictions for MRI determined through the MRI safety form.
研究者
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