Low Back PainPhase 4MioPainNCT05204667
Different Dosage Regimens of Methocarbamol/Paracetamol in Acute Non-specific Low Back Pain. MioPain Study
A Phase 4 study testing 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily and 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily in people with Low Back Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 3 sites in Italy.
Trial summary
The aim of the study is to evaluate the efficacy and safety of different dosage regimens of the combination methocarbamol/paracetamol in the treatment of patients with acute non-specific Low Back Pain. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily and 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesItaly
- Study dates
- 7 Oct 2021to 28 Feb 2024
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Male and female patients of any ethnic origin between 18 and 64 years of age (limits included).
- -Patients with current episode of acute (pain lasting less than 6 weeks) non-specific LBP, defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain, or acute exacerbation of chronic low back pain defined with a VAS score ≥ 40 mm.
- Patients with signs and symptoms of muscle spasm of the lumbar region, as clinically diagnosed by the Investigator.
- Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Patients legally capable of giving their consent to participate in the study and available to sign and date the written Informed Consent.
Who cannot join
- -1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
- 2. Lactating and pregnant women. 3. Clinically significant abnormalities on physical examination and vital signs at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.
- 4. Suspicious (according to the patient's symptoms at baseline) or confirmed COVID-19 infection at time of screening visit.
- 5. History of cervical, thoracic, or lumbosacral pain for ≥75% of the time in the last year, or any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic.
- 6. Patients with:
- serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back;
Show all 40Show fewer
- cancer, not in remission or in complete remission less than 1 year;
- active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss;
- women with polymenorrhea, endometriosis, ovarian cysts, uterine fibroids;
- widespread neurological symptoms (including cauda equina syndrome) or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizures;
- active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days;
- previous treatment with anticoagulants in the seven days before the screening visit;
- renal and/or hepatic failure;
- acute hepatitis;
- cardiac or pulmonary diseases;
- acetylsalicylic acid-triggered asthma;
- glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anemia.
- Any other condition that, in the opinion of the Investigator, interferes with the study endpoints/procedures and does not justify the inclusion of the patient in the study.
- 7. Current use of full, regular, recommended doses of any skeletal muscle relaxants/non - opioid analgesics/anti-inflammatory/NSAIDs in the 6 hours prior to the screening visit. Use is forbidden for the entire trial duration.
- 8. Current use of full, regular, recommended doses of or any medication that can alter the perception of pain (e.g., opioids, heparinoids, psychotropic agents, anti-H1 agents or glucocorticosteroids, etc.), in the 24 hours prior to the screening visit. Use is forbidden for the entire trial duration.
- Chronic intake of low doses of acetylsalicylic acid, i.e., ≤162 mg/daily, taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons could be continued for the duration of the study.
- 9. Current use of the following medications (use is forbidden for the entire trial duration):
- systemic corticosteroids;
- other drugs containing paracetamol;
- central nervous system (CNS) depressants and stimulants, including barbiturates, anaesthetics, appetite suppressants, anticonvulsants and lamotrigine (with the exception of therapeutic doses of benzodiazepines used as hypnoinducers in patients stabilised for more than one month since the screening visit);
- anticholinergic drugs; psychotropic drugs; anti-cholinesterase drugs, pyridostigmine;
- oral anticoagulants;
- chloramphenicol; rifampicin; zidovudine;
- loop diuretics;
- isoniazid; probenecid;
- propranolol;
- antiemetics;
- metoclopramide; domperidone;
- ion exchange resins (e.g. cholestyramine).
- 10. Patients undergoing physiotherapy, osteopathy or chiropractic treatments aimed to reduce LBP.
- 11. Patients treated with invasive procedures aimed to reduce LBP (e.g., epidural injections, spinal cord stimulation therapy).
- 12. History of alcoholic/substance abuse. Use of alcohol is forbidden during the entire duration of the study.
- 13. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e., uncooperative attitude, inability to return for study visits, unlikelihood of completing the clinical study); vulnerable patients (i.e., persons kept in detention).
- 14. Patients involved in the conduct of the study (i.e., Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
- 15. Participation to an interventional clinical trial within 3 months prior to Visit 0.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Sanitaria Locale Asl Al
Alessandria, 15121
Azienda Sociosanitaria Ligure Asl 3
Genova, 16125
Azienda Sociosanitaria Ligure N. 1
Sanremo, Imperia, 18038
About this study
Official title: Efficacy and Safety of Different Dosage Regimens of the Combination Methocarbamol/Paracetamol in Acute Low Back Pain (LBP): MioPain Study
The aim of the study is to evaluate the efficacy and safety of different dosage regimens of the combination methocarbamol/paracetamol in the treatment of patients with acute non-specific Low Back Pain.
Read the detailed description
This is a Phase IV, randomized, open-label, parallel-group, multicentre study.
A total of 192 patients of both sexes will be enrolled in the study and will be randomized 1:1 to one of the following 2 treatment groups:
- Group 1: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 4 times/day)
- Group 2: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 6 times/day) The expected duration of patient participation into the trial (from ICF signature up to any applicable follow up) is 8 days (± 1). Patients enrolment will be competitive among clinical sites.
The primary endpoint will be the Time to complete relief of pain, defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a VAS score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).
- Conditions
- Low Back Pain
- Being tested
- 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily, 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily
- Keywords
- low back pain, methocarbamol, paracetamol, Robaxisal compuesto
- 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.
380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times dailyDrug
Also called Robaxisal compuesto
(2 oral tablets 4 times/day up to 7 days (i.e., every 6 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water.
380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times dailyDrug
Also called Robaxisal compuesto
(2 oral tablets 6 times/day up to 7 days (i.e., every 4 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water.
| Study group | Role | What they receive |
|---|---|---|
| Methocarbamol 380 mg/paracetamol 300 mg (4 times/day) | Experimental | Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 4 times/day up to 7 days (i.e., every 6 hours±1 hour). Receives: Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily |
| Methocarbamol 380 mg/paracetamol 300 mg (6 times/day) | Active comparator | Patients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 6 times/day up to 7 days (i.e., every 4 hours±1 hour). Receives: Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete releif of pain.
The Time to complete relief of pain is defined as the time when the complete pain relief is reached.
A Complete pain relief is defined as a Visual Analogue Scale score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).
Measured: from Day1 up to Day7 (±1).
Secondary outcomes (7)
Change in Low Back Pain intensity at Visit 0 and Visit 1
Change in Low Back Pain intensity at Visit 0 and Visit 1, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Measured: Day 0 and Day 4 (±1).
Change in Low Back Pain intensity at Visit 0 and Final Visit
Change in Low Back Pain intensity at Visit 0 and Final Visit, measured by 0-10 cm (100 mm) Visual Analogue Scale, stretching from 0 "no pain" to 10 "pain as bad as it could be".
Measured: Day 0 and Day 8 (±1).
Change in the degree of improvement in the hand-to-floor distance
The Hand-to-floor distance, also called fingertip-to-floor test or mobility assessment is the vertical distance between the tip of the middle finger and the floor measured by a simple cm graduated bar (0 value at floor).
The patient will be asked to bend forward as far as possible and try to touch the floor with his/her fingers, while maintaining the knees, arms, and fingers fully extended.
Measured: Day 0, Day 4 and Day 8 (±1).
Change in the functional disability
The Functional disability is assessed by the Oswestry Disability Index (ODI) that allows to obtain information on how acute Low Back Pain affects ability to manage patients Activities of Daily Living (ADL).
The Oswestry Disability Index contains 10 sections. For each section the total possible score is 5: if the first statement is marked, the section score is=0; if the last statement is marked, it is=5. The total score of all sections as a percentage of the total achievable score is the Oswestry Disability Index score.
Measured: Day 0, Day 4 and Day 8 (±1).
Change in the Patients' Global Impression of Change scale score
The Patients' Global Impression of Change (PGIC) scale reflects a patient's belief about the efficacy of treatment evaluating all aspects of patient's health and quality of life (QoL).
It is a 7-point scale depicting a patient's rating of overall improvement: "no change", "almost the same", "a little better", "somewhat better", "moderately better", "better", or "a great deal better".
Measured: Day 0 and Day 8 (±1).
Change in the Clinical Global Impression-Improvement scale score
The Clinical Global Impression-Improvement (CGI-I) scale provides an overall clinician-determined summary evaluation of the treatment.
It is a 7-point scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from the initiation of treatment; 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Measured: Day 0 and Day 8 (±1).
Monitoring frequency of adverse events (AEs)
Safety will be assessed by monitoring the frequency of adverse events in each treatment group.
All AEs will be coded using MedDRA (Medical Dictionary for Regulatory Activities).
Measured: 8 (±1) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Oct 2021
- Primary completion3 Nov 2023
- Study completion28 Feb 2024
Why it stopped: The study had to be closed because it was not feasible to reach the estimated sample size.
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
- Model description
- This is a Phase IV, randomized, open-label, parallel-group, multicentre study.
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204667
- Sponsor's protocol ID
- 044(10A)MD20294
- Other IDs
- 2021-000067-68
- Acronym
- MioPain
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2021
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Dosage Regimens of the Combination Methocarbamol/Paracetamol in Acute Low Back Pain (LBP): MioPain Study
- ClinicalTrials.gov ID
- NCT05204667
- Acronym / sponsor ID
- MioPain / 044(10A)MD20294
- Conditions
- Low Back Pain
- Keywords
- low back pain, methocarbamol, paracetamol, Robaxisal compuesto
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study had to be closed because it was not feasible to reach the estimated sample size.
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 24 Jan 2022 (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 aim of the study is to evaluate the efficacy and safety of different dosage regimens of the combination methocarbamol/paracetamol in the treatment of patients with acute non-specific Low Back Pain.
Detailed description
This is a Phase IV, randomized, open-label, parallel-group, multicentre study.
A total of 192 patients of both sexes will be enrolled in the study and will be randomized 1:1 to one of the following 2 treatment groups:
- Group 1: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 4 times/day)
- Group 2: methocarbamol 380 mg/paracetamol 300 mg (2 oral tablets 6 times/day) The expected duration of patient participation into the trial (from ICF signature up to any applicable follow up) is 8 days (± 1). Patients enrolment will be competitive among clinical sites.
The primary endpoint will be the Time to complete relief of pain, defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a VAS score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase IV, randomized, open-label, parallel-group, multicentre study.
| Arm | Type | Receives |
|---|---|---|
| Methocarbamol 380 mg/paracetamol 300 mg (4 times/day) | Experimental | Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times dailyPatients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 4 times/day up to 7 days (i.e., every 6 hours±1 hour). |
| Methocarbamol 380 mg/paracetamol 300 mg (6 times/day) | Active comparator | Drug: 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times dailyPatients treated with two oral tablets of methocarbamol 380 mg/paracetamol 300 mg 6 times/day up to 7 days (i.e., every 4 hours±1 hour). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- -Male and female patients of any ethnic origin between 18 and 64 years of age (limits included).
- -Patients with current episode of acute (pain lasting less than 6 weeks) non-specific LBP, defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain, or acute exacerbation of chronic low back pain defined with a VAS score ≥ 40 mm.
- Patients with signs and symptoms of muscle spasm of the lumbar region, as clinically diagnosed by the Investigator.
- Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Key exclusion criteria (40 listed)
- -1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
- 2. Lactating and pregnant women. 3. Clinically significant abnormalities on physical examination and vital signs at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.
- 4. Suspicious (according to the patient's symptoms at baseline) or confirmed COVID-19 infection at time of screening visit.
- 5. History of cervical, thoracic, or lumbosacral pain for ≥75% of the time in the last year, or any other LBP episode in the last 3 months that required pharmacological treatment with an opioid analgesic.
- serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back;
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 |
|---|---|---|
| 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times dailyAlso: Robaxisal compuesto(2 oral tablets 4 times/day up to 7 days (i.e., every 6 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water. | Drug | Methocarbamol 380 mg/paracetamol 300 mg (4 times/day) |
| 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times dailyAlso: Robaxisal compuesto(2 oral tablets 6 times/day up to 7 days (i.e., every 4 hours±1 hour). Ingestion of the tablets can be helped with a small amount of water. | Drug | Methocarbamol 380 mg/paracetamol 300 mg (6 times/day) |
Primary outcome
Time to complete releif of pain.
Time frame: from Day1 up to Day7 (±1).
The Time to complete relief of pain is defined as the time when the complete pain relief is reached. A Complete pain relief is defined as a Visual Analogue Scale score ≤ 5 mm at two consecutive assessments starting from Day1 up to Day7 (±1).
7 secondary outcomes
Change in Low Back Pain intensity at Visit 0 and Visit 1
Time frame: Day 0 and Day 4 (±1).
Change in Low Back Pain intensity at Visit 0 and Final Visit
Time frame: Day 0 and Day 8 (±1).
Change in the degree of improvement in the hand-to-floor distance
Time frame: Day 0, Day 4 and Day 8 (±1).
Change in the functional disability
Time frame: Day 0, Day 4 and Day 8 (±1).
Change in the Patients' Global Impression of Change scale score
Time frame: Day 0 and Day 8 (±1).
Change in the Clinical Global Impression-Improvement scale score
Time frame: Day 0 and Day 8 (±1).
Monitoring frequency of adverse events (AEs)
Time frame: 8 (±1) days
Results and safety
The study was stopped early (reason given: The study had to be closed because it was not feasible to reach the estimated sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 380 mg/300 mg comprimidos metocarbamol/paracetamol - 4 times daily and 380 mg/300 mg comprimidos metocarbamol/paracetamol - 6 times daily in people with Low Back Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 3 sites in Italy.
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 7 inclusion and 40 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: stopped early, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
The study was stopped early (reason given: The study had to be closed because it was not feasible to reach the estimated sample size.). 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?
Time to complete releif of pain. (time frame: from Day1 up to Day7 (±1).). 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 31 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.