Low Back PainPhase 4NCT02640417
Nucleotides and B Vitamins in the Treatment of Low Back Pain
A Phase 4 study testing Nucleotides + B12 and B Vitamins in people with Low Back Pain, run by Fundação Educacional Serra dos Órgãos.
Trial summary
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Nucleotides + B12 and B Vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders, at least 18 years of age
- Clinical presentation of acute lumbago (<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
- Female subjects should be post-menopausal or using birth control
- Subjects must sign informed consent document
Who cannot join
- Intolerance to any component of the study treatments
- Pregnancy or breastfeeding
- Need for surgical treatment
- Use of other analgesic drugs
- dyshematopoiesis or coagulation disorder
- Gastric or intestinal ulcer
Show all 10Show fewer
- Gastrointestinal, cerebrovascular, or other bleeding
- Creatinine >3x% reference range
- Urea, ALT, AST, or GGT >2x% reference range
- Any other disease or condition that in the investigator's opinion should exclude the subject from the study
About this study
Official title: Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.
Read the detailed description
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.
- Conditions
- Low Back Pain
- Being tested
- Nucleotides + B12, B Vitamins
- Keywords
- Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleotides + B12Drug
Also called Group A
Oral treatment with either Nucleotides + Vitamin B12
B VitaminsDrug
Also called Group B
Oral treatment with vitamins B1, B6, and B12
| Study group | Role | What they receive |
|---|---|---|
| Nucleotides + B12 | Experimental | Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment Receives: Drug: Nucleotides + B12 |
| B vitamins | Active comparator | Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment Receives: Drug: B Vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Occurrence
Percentage of subjects in each treatment group presenting with adverse events
Measured: Throughout 60 day treatment period
Secondary outcomes (3)
Low back pain Questionnaire
Percentage of subjects in each treatment group presenting improvement of >5 points in Questionnaire scores
Measured: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Visual Analog Pain Scores
Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment
Measured: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Finger-to-Floor Distance
Percentage of subjects in each treatment group presenting improvement of >3cm in finger to floor distance in relation to pretreatment values
Measured: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionOct 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Antonio Naslausky Mibielli, Fundação Educacional Serra dos Órgãos
- Investigators
- Marco AN Mibielli, MD, Principal investigator, UNIFESO - Fundação Educacional Serra dos Órgãos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640417
- Sponsor's protocol ID
- NHCN-03-12-15
- Status last verified
- Apr 2019
- First submitted
- 15 Dec 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos
- ClinicalTrials.gov ID
- NCT02640417
- Acronym / sponsor ID
- NHCN-03-12-15
- Conditions
- Low Back Pain
- Keywords
- Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.
Detailed description
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nucleotides + B12 | Experimental | Drug: Nucleotides + B12Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment |
| B vitamins | Active comparator | Drug: B VitaminsVitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both genders, at least 18 years of age
- Clinical presentation of acute lumbago (<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
- Female subjects should be post-menopausal or using birth control
- Subjects must sign informed consent document
Key exclusion criteria (10 listed)
- Intolerance to any component of the study treatments
- Pregnancy or breastfeeding
- Need for surgical treatment
- Use of other analgesic drugs
- dyshematopoiesis or coagulation disorder
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 |
|---|---|---|
| Nucleotides + B12Also: Group AOral treatment with either Nucleotides + Vitamin B12 | Drug | Nucleotides + B12 |
| B VitaminsAlso: Group BOral treatment with vitamins B1, B6, and B12 | Drug | B vitamins |
Primary outcome
Adverse Event Occurrence
Time frame: Throughout 60 day treatment period
Percentage of subjects in each treatment group presenting with adverse events
3 secondary outcomes
Low back pain Questionnaire
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Visual Analog Pain Scores
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Finger-to-Floor Distance
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
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 19 Apr 2019.
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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.
Marco AN Mibielli, MD principal investigator
UNIFESO - Fundação Educacional Serra dos Órgãos
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nucleotides + B12 and B Vitamins in people with Low Back Pain, run by Fundação Educacional Serra dos Órgãos.
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 4 inclusion and 10 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Adverse Event Occurrence (time frame: Throughout 60 day treatment period). 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 19 Apr 2019.