Spinal TumorPhase 4NCT05106179
The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma
A Phase 4 study testing Atenolol Pill and Propranolol Pill in people with Spinal Tumor and Spinal Hemangioma, run by Center for Vascular Pathology, Moscow at 1 site in Russia.
Trial summary
Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal. This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
- What is being tested?
- Atenolol Pill and Propranolol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2021to Dec 2023
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- vertebral hemangioma
Who cannot join
- symptomatic bradycardia
- AV block
- decompensated heart failure
- asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma: a Prospective Cohort Study
Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal.
This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.
- Conditions
- Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
- Being tested
- Atenolol Pill, Propranolol Pill
- Keywords
- β-blockers, Vertebral Hemangioma, Efficacy
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atenolol PillDrug
Atenolol is a second-generation hydrophilic β-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys.
Propranolol PillDrug
Propranolol is highly lipophilic, nonselective β-blockers, which is primarily metabolised by the liver.
| Study group | Role | What they receive |
|---|---|---|
| Previously treated + Atenolol | Active comparator | The investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately Receives: Drug: Atenolol Pill |
| Previously treated + Propranolol | Active comparator | The investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately Receives: Drug: Propranolol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing tumor growth
MRI
Measured: 3 months
Reducing tumor
MRI
Measured: 6 months
Life-quality
Valid questionnaires based on the ones, approved by EuroQol Organization
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vascular Pathology, Moscow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina Listovskaia, MD, Study chair, The Vascular Anomalies Center (VAC) "Hemangioma",Dmitry Romanov, MD, Study chair, The Vascular Anomalies Center (VAC) "Hemangioma"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106179
- Sponsor's protocol ID
- S_Hemangioma
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05106179
- Acronym / sponsor ID
- S_Hemangioma
- Conditions
- Spinal Tumor, Spinal Hemangioma, Beta Blocker Toxicity
- Keywords
- β-blockers, Vertebral Hemangioma, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Center for Vascular Pathology, MoscowUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal.
This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously treated + Atenolol | Active comparator | Drug: Atenolol PillThe investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately |
| Previously treated + Propranolol | Active comparator | Drug: Propranolol PillThe investigators suppose the outcome might be compromised if patient has been previously treated, that's why it is going to be compared to the main cohort. The results are going to be analysed separately |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- vertebral hemangioma
Key exclusion criteria (4 listed)
- symptomatic bradycardia
- AV block
- decompensated heart failure
- asthma
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 |
|---|---|---|
| Atenolol PillAtenolol is a second-generation hydrophilic β-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys. | Drug | Previously treated + Atenolol |
| Propranolol PillPropranolol is highly lipophilic, nonselective β-blockers, which is primarily metabolised by the liver. | Drug | Previously treated + Propranolol |
Primary outcome
Reducing tumor growth
Time frame: 3 months
MRI
Reducing tumor
Time frame: 6 months
MRI
Life-quality
Time frame: 3 months and 6 months
Valid questionnaires based on the ones, approved by EuroQol Organization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- 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.
Ekaterina Listovskaia, MD study chair
The Vascular Anomalies Center (VAC) "Hemangioma",
Dmitry Romanov, MD study chair
The Vascular Anomalies Center (VAC) "Hemangioma"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atenolol Pill and Propranolol Pill in people with Spinal Tumor and Spinal Hemangioma, run by Center for Vascular Pathology, Moscow at 1 site in Russia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Nov 2021. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reducing tumor growth (time frame: 3 months). The study lists 3 primary outcomes in all. 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 3 Nov 2021.