- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145310
BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
December 7, 2022 updated by: Breath of Life International Pharma Ltd
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petach Tikva, Israel
- Beilinson Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
|
sublingual drops
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Placebo Comparator: Arm B
|
sublingual drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to Day 114
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Index
Time Frame: Baseline to Day 100
|
Change in the Brief Pain Index relative to baseline.
The Brief Pain Inventory rapidly assesses the severity of pain and its impact on functioning
|
Baseline to Day 100
|
Short Form (SF12) Mental
Time Frame: Screening to Day 100
|
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
|
Screening to Day 100
|
Pittsburgh Sleep Quality Index
Time Frame: Screening to Day 100
|
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
|
Screening to Day 100
|
Opiate consumption and analgesic medication consumption
Time Frame: Screening to Day 100
|
Change in Opiate consumption and analgesic medication consumption
|
Screening to Day 100
|
Patient Global Impression
Time Frame: Baseline to Day 100
|
Change in Patient global impression.
The Patient Global Impression is a 7 point scale depicting a patient's rating of overall improvement
|
Baseline to Day 100
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2018
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
July 7, 2022
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (Actual)
October 30, 2019
Study Record Updates
Last Update Posted (Estimate)
December 8, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOL-P-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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