Phase 1: Pain ManagementPhase 1/2NCT02654860
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia
A Phase 1/2 study testing Paracetamol 3% and Hyperbaric Bupivacaine HCl 0.5% in people with Phase 1: Pain Management and Phase 2: Pain Management, run by Sintetica SA at 1 site in Switzerland.
Trial summary
Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Phase 1: Pain Management, Phase 2: Pain Management
- What is being tested?
- Paracetamol 3% and Hyperbaric Bupivacaine HCl 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Feb 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study
- Sex, age and surgery: male/female 18-80 years (inclusive) old patients, scheduled for hip replacement surgery, with anticipated need for post-operative narcotic analgesia, adequate i.v. access and anticipated hospital stay > 48 hours.
- Body Mass Index (BMI): 18 - 34 kg/m2 inclusive
- ASA physical status: I-III
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- Inclusion criteria - Phase 1 only : Age: 18-70 (inclusive) old patients
- Inclusion criteria - Phase 2 only : Age: 18-80 (inclusive) old patients Hospital stay: Patients with anticipated hospital stay > 48 hours
Who cannot join
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: IV-V
- Further anaesthesia: patients expected to require further anaesthesia
- Pain assessment: anticipated to be unable to make a reliable self-report of pain intensity
- Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or amide type anaesthetics) and/or formulations' ingredients or related drugs, opioids, non-steroidal anti-inflammatory drugs; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes, other neuropathies, history or evidence of asthma or heart failure. History of severe head trauma that required hospitalisation, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
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- Liver function: Impaired liver function (transaminases > twice upper limit)
- Renal function: Renal dysfunction (creatinine > 2.0 mg/dL)
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
- Drug, alcohol: history of drug or alcohol abuse. Pre-existing dependence on narcotics or known tolerance to opioids
- Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating women [The pregnancy test will be performed to all fertile women and to all women up to 55 years old, if not in proven menopause (available laboratory test confirming menopause or surgically sterilised)]
- Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, anticonvulsant agents or chronic analgesic therapy).
- Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Paracetamol formulations, other than the investigational product, for 1 week before the start of the study and during the study. Hormonal contraceptives for females are allowed.
- Phase 2 only - Exclusion criteria Pain assessment: anticipated to be unable to make a reliable self-report of pain intensity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-part Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia in Patients Scheduled for Hip Replacement Surgery
Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery
Read the detailed description
This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The objective of the study is to investigate the efficacy and safety of a single intrathecal injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared to placebo solution, for post-operative analgesia of hip replacement surgery performed under spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160 cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol IT and bupivacaine IT administrations should not exceed 2 min.
The study will include a screening phase (Visit 1, Days -21/1), a treatment phase (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3, from Day 1 after surgery until discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a 0-100 mm VAS.
- Conditions
- Phase 1: Pain Management, Phase 2: Pain Management
- Being tested
- Paracetamol 3%, Placebo injection containing Saline solution 0.9%, Hyperbaric Bupivacaine HCl 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 3%Drug
Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery
Placebo injection containing Saline solution 0.9%Drug
Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.
Hyperbaric Bupivacaine HCl 0.5%Drug
NIMP, spinal anaesthetic before the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| 60 mg Paracetamol 3% (2 mL) | Experimental | 60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Receives: Drug: Paracetamol 3%; Drug: Hyperbaric Bupivacaine HCl 0.5% |
| 90 mg Paracetamol 3% (3 mL) | Experimental | 90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Receives: Drug: Paracetamol 3%; Drug: Hyperbaric Bupivacaine HCl 0.5% |
| 120 mg Paracetamol 3% (4mL) | Experimental | 120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Receives: Drug: Paracetamol 3%; Drug: Hyperbaric Bupivacaine HCl 0.5% |
| Phase II Only: Saline solution 0.9% | Placebo comparator | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Receives: Drug: Placebo injection containing Saline solution 0.9%; Drug: Hyperbaric Bupivacaine HCl 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol
Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled
Measured: In the first 24 hours, in the first 48 hours and at day 7±1
Phase 2: Pain Intensity
Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation)
Measured: baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge
Secondary outcomes (12)
Phase 2: Morphine
Phase 2: Total morphine use
Measured: At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days
Phase 2: Time to First Morphine Use
Phase 2: Time to first morphine use (minutes)
Measured: Postoperative, up to 48 hours after end of surgery
Phase 2: Number of Participants With Need for Supplemental Analgesia
Phase 2: Need for supplementary analgesia, other than the planned morphine PCA
Measured: Postoperative, up to 48 hours after end of surgery
Phase 2: Morphine-related Adverse Events
Percentage of subjects experiencing during the study the morphine-related adverse events pre-specified in the protocol
Measured: up to 24 hours after surgery, up to 48 hours
Phase 2: Time to Readiness for Surgery
Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery.
Measured: Intraoperative
Phase 2:Maximum Level of Sensory Block
Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0)
Measured: Intraoperative
Phase 2: Time to Sensory Block
Time to maximum level of sensory block
Measured: Intraoperative
Phase 2: Time to Regression of Spinal Block
Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale:
I - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet
Measured: from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block
Phase 2: Vital Signs
Systolic and Diastolic Blood Pressure (mmHg)
Measured: at screening, at baseline (before the spinal injection) and at end of the study (Day 6).
Phase2: Concomitant Medications
record the concomitant medications intaked during the study
Measured: at screening, at baseline until the end of the study (Day 6)
Phase 2: SpO2
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood.
Measured: at screening, at baseline (before the spinal injection) and at the end of the study (day 6)
Phase 2: ECG
Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin.
Measured: screening, baseline and end of study (Day 6±1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Phase 1: Pain ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 arms for Phase II only
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Responsible party
- Sponsor
- Investigators
- Claudio Camponovo, MD, Principal investigator, Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654860
- Sponsor's protocol ID
- PAR.3/02-2015
- Status last verified
- Jul 2021
- First submitted
- 23 Dec 2015
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-part Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia in Patients Scheduled for Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT02654860
- Acronym / sponsor ID
- PAR.3/02-2015
- Conditions
- Phase 1: Pain Management, Phase 2: Pain Management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Collaborators
- Cross S.A.
- Study start
- Nov 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery
Detailed description
This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The objective of the study is to investigate the efficacy and safety of a single intrathecal injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared to placebo solution, for post-operative analgesia of hip replacement surgery performed under spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160 cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol IT and bupivacaine IT administrations should not exceed 2 min.
The study will include a screening phase (Visit 1, Days -21/1), a treatment phase (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3, from Day 1 after surgery until discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a 0-100 mm VAS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 4 arms for Phase II only
| Arm | Type | Receives |
|---|---|---|
| 60 mg Paracetamol 3% (2 mL) | Experimental | Drug: Paracetamol 3%, Drug: Hyperbaric Bupivacaine HCl 0.5%60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
| 90 mg Paracetamol 3% (3 mL) | Experimental | Drug: Paracetamol 3%, Drug: Hyperbaric Bupivacaine HCl 0.5%90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
| 120 mg Paracetamol 3% (4mL) | Experimental | Drug: Paracetamol 3%, Drug: Hyperbaric Bupivacaine HCl 0.5%120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
| Phase II Only: Saline solution 0.9% | Placebo comparator | Drug: Placebo injection containing Saline solution 0.9%, Drug: Hyperbaric Bupivacaine HCl 0.5%Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent: signed written informed consent before inclusion in the study
- Sex, age and surgery: male/female 18-80 years (inclusive) old patients, scheduled for hip replacement surgery, with anticipated need for post-operative narcotic analgesia, adequate i.v. access and anticipated hospital stay > 48 hours.
- Body Mass Index (BMI): 18 - 34 kg/m2 inclusive
- ASA physical status: I-III
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (14 listed)
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- ASA physical status: IV-V
- Further anaesthesia: patients expected to require further anaesthesia
- Pain assessment: anticipated to be unable to make a reliable self-report of pain intensity
- Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or amide type anaesthetics) and/or formulations' ingredients or related drugs, opioids, non-steroidal anti-inflammatory drugs; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
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 |
|---|---|---|
| Paracetamol 3%Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery | Drug | 120 mg Paracetamol 3% (4mL), 60 mg Paracetamol 3% (2 mL), 90 mg Paracetamol 3% (3 mL) |
| Placebo injection containing Saline solution 0.9%Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. | Drug | Phase II Only: Saline solution 0.9% |
| Hyperbaric Bupivacaine HCl 0.5%NIMP, spinal anaesthetic before the surgical procedure | Drug | 120 mg Paracetamol 3% (4mL), 60 mg Paracetamol 3% (2 mL), 90 mg Paracetamol 3% (3 mL), Phase II Only: Saline solution 0.9% |
Primary outcome
Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol
Time frame: In the first 24 hours, in the first 48 hours and at day 7±1
Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled
Phase 2: Pain Intensity
Time frame: baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge
Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation)
12 secondary outcomes
Phase 2: Morphine
Time frame: At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days
Phase 2: Time to First Morphine Use
Time frame: Postoperative, up to 48 hours after end of surgery
Phase 2: Number of Participants With Need for Supplemental Analgesia
Time frame: Postoperative, up to 48 hours after end of surgery
Phase 2: Morphine-related Adverse Events
Time frame: up to 24 hours after surgery, up to 48 hours
Phase 2: Time to Readiness for Surgery
Time frame: Intraoperative
Phase 2:Maximum Level of Sensory Block
Time frame: Intraoperative
Phase 2: Time to Sensory Block
Time frame: Intraoperative
Phase 2: Time to Regression of Spinal Block
Time frame: from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block
Phase 2: Vital Signs
Time frame: at screening, at baseline (before the spinal injection) and at end of the study (Day 6).
Phase2: Concomitant Medications
Time frame: at screening, at baseline until the end of the study (Day 6)
Phase 2: SpO2
Time frame: at screening, at baseline (before the spinal injection) and at the end of the study (day 6)
Phase 2: ECG
Time frame: screening, baseline and end of study (Day 6±1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Claudio Camponovo, MD principal investigator
Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland
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 Paracetamol 3% and Hyperbaric Bupivacaine HCl 0.5% in people with Phase 1: Pain Management and Phase 2: Pain Management, run by Sintetica SA at 1 site in Switzerland.
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 14 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 27 Oct 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol (time frame: In the first 24 hours, in the first 48 hours and at day 7±1). The study lists 2 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 27 Oct 2021.