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

Sponsor
Breath of Life International Pharma Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04145310
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
37.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BOL-DP-o-04 + SCO
  • Drug: Placebo + SCO
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
Actual Study Start Date :
Nov 27, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: BOL-DP-o-04 + SCO
sublingual drops
Placebo Comparator: Arm B

Drug: Placebo + SCO
sublingual drops

Outcome Measures

Primary Outcome Measures

  1. Oswestry Disability Index [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.

Secondary Outcome Measures

  1. Brief Pain Index [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

  2. Short Form (SF12) Mental [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

  3. Pittsburgh Sleep Quality Index [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

  4. Opiate consumption and analgesic medication consumption [Screening to Day 100]

    Change in Opiate consumption and analgesic medication consumption

  5. Patient Global Impression [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beilinson Medical Center Petach Tikva Israel

Sponsors and Collaborators

  • Breath of Life International Pharma Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Breath of Life International Pharma Ltd
ClinicalTrials.gov Identifier:
NCT04145310
Other Study ID Numbers:
  • BOL-P-11
First Posted:
Oct 30, 2019
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sciatica
Back Pain
Low Back Pain

Study Results

No Results Posted as of Sep 2, 2021