NCT04145310CompletedPhase 1
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
Breath of Life International Pharma Ltd1 site in 1 country26 target enrollmentStarted: November 27, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>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
Exclusion Criteria
- •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
Arms & Interventions
Arm A
Experimental
Intervention: BOL-DP-o-04 + SCO (Drug)
Arm B
Placebo Comparator
Intervention: Placebo + SCO (Drug)
Outcomes
Primary Outcomes
Oswestry Disability Index
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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