BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

Low Back Pain Clinical Trial

Official title:

A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145310
• Other study ID #: BOL-P-11
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 27, 2018
• Est. completion date: July 7, 2022

Study information

• Verified date: December 2022
• Source: Breath of Life International Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sciatica

Intervention

Drug:
• BOL-DP-o-04 + SCO
sublingual drops
• Placebo + SCO
sublingual drops

Locations

Country	Name	City	State
Israel	Beilinson Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Breath of Life International Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Day 114
Secondary	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	Baseline to Day 100
Secondary	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	Screening to Day 100
Secondary	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	Screening to Day 100
Secondary	Opiate consumption and analgesic medication consumption	Change in Opiate consumption and analgesic medication consumption	Screening to Day 100
Secondary	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	Baseline to Day 100