Clinical trial NCT04145310: BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
Official title: A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Sciatica
Lead sponsor: Breath of Life International Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Mild to Severe Low Back Pain and/or Sciatica
3. Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms
4. Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures
5. Signed and dated Informed Consent Form (ICF)
6. Non-responsive to standard therapy for at least 1 month

Exclusion Criteria:

1. VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain)
2. Known allergy to cannabis or its components
3. A patient who is pregnant or intends to become pregnant during the study
4. A patient who is nursing or intends to nurse during the study
5. A patient suffering from a mental disorder precluding administration of study drug
6. Prisoners
7. A Patient is unable to sign an informed consent form
8. Unstable angina pectoris
9. Cardiac insufficiency precluding cannabis administration
10. Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician
11. Known Aspergillus infection
12. Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview
13. Any mental/psychiatric illness in first-degree relative in a young patient \< 30-year-old.
14. Patient with congestive heart failure
15. Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline to Day 114
Secondary outcomes:
measure: Brief Pain Index
timeFrame: Baseline to Day 100
measure: Short Form (SF12) Mental
timeFrame: Screening to Day 100
measure: Pittsburgh Sleep Quality Index
timeFrame: Screening to Day 100
measure: Opiate consumption and analgesic medication consumption
timeFrame: Screening to Day 100
measure: Patient Global Impression
timeFrame: Baseline to Day 100
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center
Study officials:
References: