NCT06717867进行中（未招募）2 期
A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change from baseline to the end of the study period in participants with SAEs
研究概览
简要总结
The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers.
The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation.
Participants will:
- Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process.
- Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study.
- Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call.
- During visits there will be safety assessments performed, blood sampling and questionnaires.
The trial will include two participation modes:
- In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility.
- Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.
详细描述
This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18 years and older)
- •Generally healthy
- •Able to provide informed consent
- •BMI 18.5 - 35.0 kg/m2
- •Agree to not participate in another clinical trial during enrolment period
排除标准
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
- •Unstable illness (e.g., diabetes and thyroid gland dysfunction)
- •History of renal function impairment
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy [(excluding low dose aspirin (under 300 mg/day)]
- •Regular consumption (>4 times a week) of PEA over the past 2 weeks
- •Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
- •Chronic past (within 12-months) and/or current alcohol use (>14 alcoholic drinks week)
- •Pregnant or lactating women
- •Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
- •Has a clinically significant abnormal finding on the medical assessment, medical history, or clinical laboratory results at screening.
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
研究组 & 干预措施
PEA (Levagen)
Experimental
600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.
干预措施: Palmitoylethanolamide (PEA) (Dietary Supplement)
Placebo
Placebo Comparator
600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline to the end of the study period in participants with SAEs
时间窗: From Day O (Baseline) to 54 weeks
Change from baseline to the end of the study period in: Number of participants with Serious Adverse Events (SAE) after first administration of study drug through to the last dose of study drug plus 2 weeks \[time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)\]
次要结局
- Change from baseline to month 12 in Gastrointestinal tolerance questionnaire(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in anxiety questionnaires(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Quality of life(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Musculoskeletal health questionnaire(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in medical assessment(Baseline (day 0) and Month 12)
- Change from baseline to month 12 in Vital Signs (blood pressure)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Vital Signs (heart rate)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (insulin)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (lipids).(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (electrolytes)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in sleep questionnaires.(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Vital Signs (heart rate)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in AEs(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in medical assessment(Baseline (day 0) and Month 12)
- Change from baseline to month 12 in Vital Signs (blood pressure)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (lipids).(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (electrolytes)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in sleep questionnaires.(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in anxiety questionnaires(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Quality of life(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in clinical laboratory determinations (insulin)(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Musculoskeletal health questionnaire(Baseline (Day 0) to month 12.)
- Change from baseline to month 12 in Gastrointestinal tolerance questionnaire(Baseline (Day 0) to month 12.)
研究者
研究点 (3)
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