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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
Breath of Life International Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
October 29, 2019
Last Updated
December 7, 2022
Sponsor
Breath of Life International Pharma Ltd
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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

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