Low Back PainPhase 1/2NCT04145310
BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
A Phase 1/2 study testing BOL-DP-o-04 + SCO in people with Low Back Pain and Sciatica, run by Breath of Life International Pharma Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Sciatica
- What is being tested?
- BOL-DP-o-04 + SCO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Nov 2018to 7 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Sciatica
- Being tested
- BOL-DP-o-04 + SCO, Placebo + SCO
- Medical subject headings
- Low Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-DP-o-04 + SCODrug
sublingual drops
Placebo + SCODrug
sublingual drops
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BOL-DP-o-04 + SCO |
| Arm B | Placebo comparator | Not described Receives: Drug: Placebo + SCO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 114
Secondary outcomes (5)
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
Measured: Baseline to Day 100
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
Measured: Screening to Day 100
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
Measured: Screening to Day 100
Opiate consumption and analgesic medication consumption
Change in Opiate consumption and analgesic medication consumption
Measured: Screening to Day 100
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
Measured: Baseline to Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start27 Nov 2018
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breath of Life International Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145310
- Sponsor's protocol ID
- BOL-P-11
- Status last verified
- Dec 2022
- First submitted
- 29 Oct 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients With Low Back Pain and Sciatica
- ClinicalTrials.gov ID
- NCT04145310
- Acronym / sponsor ID
- BOL-P-11
- Conditions
- Low Back Pain, Sciatica
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Breath of Life International Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BOL-DP-o-04 + SCO |
| Arm B | Placebo comparator | Drug: Placebo + SCO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOL-DP-o-04 + SCOsublingual drops | Drug | Arm A |
| Placebo + SCOsublingual drops | Drug | Arm B |
Primary outcome
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.
5 secondary outcomes
Brief Pain Index
Time frame: Baseline to Day 100
Short Form (SF12) Mental
Time frame: Screening to Day 100
Pittsburgh Sleep Quality Index
Time frame: Screening to Day 100
Opiate consumption and analgesic medication consumption
Time frame: Screening to Day 100
Patient Global Impression
Time frame: Baseline to Day 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOL-DP-o-04 + SCO in people with Low Back Pain and Sciatica, run by Breath of Life International Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Baseline to Day 114). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.