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NCT Number: NCT04145310

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.

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Key information

Conditions

Low Back Pain Back Pain Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beilinson Medical Center

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOL-DP-o-04 + SCO

Drug

sublingual drops

Placebo + SCO

Drug

sublingual drops

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Opiate consumption and analgesic medication consumption

    Time frame: Screening to Day 100

    Change in Opiate consumption and analgesic medication consumption

  5. 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

Sponsors and collaborators

Lead sponsor

Breath of Life International Pharma Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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