BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
NCT ID: NCT04145310
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2018-11-27
2022-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
BOL-DP-o-04 + SCO
sublingual drops
Arm B
Placebo + SCO
sublingual drops
Interventions
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BOL-DP-o-04 + SCO
sublingual drops
Placebo + SCO
sublingual drops
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Breath of Life International Pharma Ltd
INDUSTRY
Responsible Party
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Locations
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Beilinson Medical Center
Petah Tikva, , Israel
Countries
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Other Identifiers
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BOL-P-11
Identifier Type: -
Identifier Source: org_study_id
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