NCT04145310已完成1 期
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
详细描述
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients with Low Back Pain and Sciatica. The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Mild to Severe Low Back Pain and/or Sciatica
- •Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms
- •Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures
- •Signed and dated Informed Consent Form (ICF)
- •Non-responsive to standard therapy for at least 1 month
排除标准
- •VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain)
- •Known allergy to cannabis or its components
- •A patient who is pregnant or intends to become pregnant during the study
- •A patient who is nursing or intends to nurse during the study
- •A patient suffering from a mental disorder precluding administration of study drug
- •A Patient is unable to sign an informed consent form
- •Unstable angina pectoris
- •Cardiac insufficiency precluding cannabis administration
- •Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician
- •Known Aspergillus infection
- •Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview
- •Any mental/psychiatric illness in first-degree relative in a young patient < 30-year-old.
- •Patient with congestive heart failure
- •Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
研究组 & 干预措施
Arm A
Experimental
干预措施: BOL-DP-o-04 + SCO (Drug)
Arm B
Placebo Comparator
干预措施: Placebo + SCO (Drug)
结局指标
主要结局
Oswestry Disability Index
时间窗: Baseline to Day 114
Change in the Oswestry Disability Index. The questionnaire is composed by 10 sections Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.
次要结局
- Short Form (SF12) Mental(Screening to Day 100)
- Patient Global Impression(Baseline to Day 100)
- Pittsburgh Sleep Quality Index(Screening to Day 100)
- Brief Pain Index(Baseline to Day 100)
- Opiate consumption and analgesic medication consumption(Screening to Day 100)
研究者
研究点 (1)
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