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

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

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:

  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

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
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

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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