BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
Primary Purpose
Low Back Pain, Sciatica
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
BOL-DP-o-04 + SCO
Placebo + SCO
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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
- Prisoners
- 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
Sites / Locations
- Beilinson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
Oswestry Disability Index
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 Outcome Measures
Brief Pain Index
Change in the Brief Pain Index relative to baseline. The Brief Pain Inventory rapidly assesses the severity of pain and its impact on functioning
Short Form (SF12) Mental
Change in Short Form (SF12) Mental Composite Score.The SF-12 consists of a subset of 12 items that measure eight health domains to assess physical and mental health
Pittsburgh Sleep Quality Index
Change in Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score
Opiate consumption and analgesic medication consumption
Change in Opiate consumption and analgesic medication consumption
Patient Global Impression
Change in Patient global impression. The Patient Global Impression is a 7 point scale depicting a patient's rating of overall improvement
Full Information
NCT ID
NCT04145310
First Posted
October 29, 2019
Last Updated
December 7, 2022
Sponsor
Breath of Life International Pharma Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04145310
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breath of Life International Pharma Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Sciatica
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BOL-DP-o-04 + SCO
Intervention Description
sublingual drops
Intervention Type
Drug
Intervention Name(s)
Placebo + SCO
Intervention Description
sublingual drops
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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.
Time Frame
Baseline to Day 114
Secondary Outcome Measure Information:
Title
Brief Pain Index
Description
Change in the Brief Pain Index relative to baseline. The Brief Pain Inventory rapidly assesses the severity of pain and its impact on functioning
Time Frame
Baseline to Day 100
Title
Short Form (SF12) Mental
Description
Change in Short Form (SF12) Mental Composite Score.The SF-12 consists of a subset of 12 items that measure eight health domains to assess physical and mental health
Time Frame
Screening to Day 100
Title
Pittsburgh Sleep Quality Index
Description
Change in Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score
Time Frame
Screening to Day 100
Title
Opiate consumption and analgesic medication consumption
Description
Change in Opiate consumption and analgesic medication consumption
Time Frame
Screening to Day 100
Title
Patient Global Impression
Description
Change in Patient global impression. The Patient Global Impression is a 7 point scale depicting a patient's rating of overall improvement
Time Frame
Baseline to Day 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Prisoners
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
Facility Information:
Facility Name
Beilinson Medical Center
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
We'll reach out to this number within 24 hrs