Symptomatic Uterine Fibroids and AdenomyosisPhase 4NCT02227316
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
A Phase 4 study testing IV Ibuprofen and IV Acetaminophen in people with Symptomatic Uterine Fibroids and Adenomyosis, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Symptomatic Uterine Fibroids and Adenomyosis
- What is being tested?
- IV Ibuprofen and IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Sep 2016
- Phase
- Phase 4
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients being considered for UFE including bleeding and/or bulk symptoms.
- Women of all ethnicities
- Ages 21-60
Who cannot join
- Patients with current malignancy receiving treatment
- Women who are pregnant
- Cognitive impairment
- Clinically significant kidney disease
- Clinically significant liver disease
- Any recent history of gastrointestinal bleed or ulcer
Show all 12Show fewer
- Weight less than 50 kg (medication dosing requirements change below 50 kg)
- Women with a body mass index (BMI) equal to or over 50 (with other co-morbidities)
- Known allergy or hypersensitivity to NSAID or acetaminophen
- Administration of acetaminophen, NSAID, narcotic or any other analgesic less than 6 hours prior to UFE procedure
- Any chronic use of pain medications including acetaminophen, NSAID, narcotic or analgesic
- Patients who cannot or choose not to consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Santa Monica/UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California, 90404
About this study
Official title: A Prospective, Double Blind, Randomized, Placebo Controlled Study to Compare the Effectiveness of Intravenous Acetaminophen and Intravenous Ibuprofen in Reducing Post Procedural Pain in the Uterine Fibroid Embolization Procedure
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medications, including opiates.
Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea medications such as ondansetron and prochlorperazine.
Read more
This study is being conducted to compare two new medications for pain, IV ibuprofen and IV acetaminophen, administered for 24 hours following UFE. The primary safety objective of non-inferiority will be met and the primary efficacy objective of superiority, decreased pain and nausea, will be accessed when compared to current standard of care regimens.
This is a 4 arm, double blind, randomized, controlled study. All patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure. The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These medications will be given during the procedure and extended over a 24 hour stay.
Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.
Read the detailed description
A prospective, double blind, randomized controlled trial evaluating the effects of two new IV medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic management in Uterine Fibroid Embolization patients.
- Four arm, double blind, randomized controlled study: all patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone during the procedure, followed by a hydromorphone PCA infusion pump during their recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo). The same amount of normal saline will be substituted for the experimental treatments if the patient receives the placebo. These medications will be given during the procedure and extended over a 24 hour recovery period. The medications given will be blinded to the patient, the administrator, and the surveyor.
- The placebo/placebo arm would replicate current standard of care, and therefore include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control for 24 hours at q6hour dosing to the other three arms.
- Dosage of medications will be standardized based on formulary indications: IV Ketorolac 30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours, ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.
- Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication requirements. Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24 hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured at 24 hours using the validated APS-POQ-R questionnaire (6).
- Other variables recorded: Age, height, weight, history of postoperative nausea and vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy time for the procedure.
- Technical parameters, which would remain constant, include: pre procedure and 6 month follow up MRI contrast with gadolinium which is standard of care, embolization using 500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours, IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity compression devices, and early ambulation.
- In the interim analysis, the investigators will have 40 subjects in total with unequal randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35 subjects per arm for the final analysis (sum total N=140)
- Being tested
- IV Ibuprofen, IV Acetaminophen, Intravenous placebo/Intravenous placebo
- Keywords
- Uterine Fibroid Embolization, Pain, UFE, Fibroids, Adenomyosis, Bleeding, IV Acetaminophen, IV Ibuprofen, Menorrhagia, Leiomyoma, Patient Satisfaction
- Medical subject headings
- Adenomyosis, Pain, Leiomyoma, Hemorrhage, Menorrhagia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV IbuprofenDrug
Also called Uterine artery embolization
Uterine fibroid embolization
IV AcetaminophenDrug
Also called Uterine artery embolization
Uterine fibroid embolization
Intravenous placebo/Intravenous placeboDrug
Also called Uterine artery embolization
Uterine fibroid embolization
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization Receives: Drug: IV Ibuprofen |
| Intravenous acetaminophen | Experimental | Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization Receives: Drug: IV Acetaminophen |
| IV ibuprofen/IV acetaminophen | Experimental | Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization Receives: Drug: IV Ibuprofen; Drug: IV Acetaminophen |
| Intravenous placebo/Intravenous placebo | Active comparator | Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization Receives: Drug: Intravenous placebo/Intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Measured: 24 hours
Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Measured: 24 hours
Secondary outcomes (4)
Mean Nausea Intensity
Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
Measured: 24 hours
Opioid Consumption
Mean opioid consumption in morphine equivalents over 24 hours
Measured: 24 hours
Anti-Emetic Consumption
Mean dose of anti-emetic medication in milligrams given over 24 hours
Measured: 24 hours
Maximum Nausea Intensity
Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionSep 2016
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 Symptomatic Uterine Fibroids and AdenomyosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor Name Pending
- Responsible party
- Principal investigator, Cheryl Hoffman, University of California, Los Angeles
- Investigators
- Cheryl H Hoffman, MD, Principal investigator, University of California, Los AngelesJonathan S Jahr, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227316
- Sponsor's protocol ID
- 14000359
- Status last verified
- Jun 2018
- First submitted
- 26 Aug 2014
- Last updated
- 8 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Placebo Controlled Study to Compare the Effectiveness of Intravenous Acetaminophen and Intravenous Ibuprofen in Reducing Post Procedural Pain in the Uterine Fibroid Embolization Procedure
- ClinicalTrials.gov ID
- NCT02227316
- Acronym / sponsor ID
- 14000359
- Keywords
- Uterine Fibroid Embolization, Pain, UFE, Fibroids, Adenomyosis, Bleeding, IV Acetaminophen, IV Ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Sponsor Name Pending
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medications, including opiates.
Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea medications such as ondansetron and prochlorperazine.
This study is being conducted to compare two new medications for pain, IV ibuprofen and IV acetaminophen, administered for 24 hours following UFE. The primary safety objective of non-inferiority will be met and the primary efficacy objective of superiority, decreased pain and nausea, will be accessed when compared to current standard of care regimens.
This is a 4 arm, double blind, randomized, controlled study. All patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure. The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These medications will be given during the procedure and extended over a 24 hour stay.
Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.
Detailed description
A prospective, double blind, randomized controlled trial evaluating the effects of two new IV medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic management in Uterine Fibroid Embolization patients.
- Four arm, double blind, randomized controlled study: all patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone during the procedure, followed by a hydromorphone PCA infusion pump during their recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo). The same amount of normal saline will be substituted for the experimental treatments if the patient receives the placebo. These medications will be given during the procedure and extended over a 24 hour recovery period. The medications given will be blinded to the patient, the administrator, and the surveyor.
- The placebo/placebo arm would replicate current standard of care, and therefore include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control for 24 hours at q6hour dosing to the other three arms.
- Dosage of medications will be standardized based on formulary indications: IV Ketorolac 30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours, ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.
- Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication requirements. Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24 hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured at 24 hours using the validated APS-POQ-R questionnaire (6).
- Other variables recorded: Age, height, weight, history of postoperative nausea and vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy time for the procedure.
- Technical parameters, which would remain constant, include: pre procedure and 6 month follow up MRI contrast with gadolinium which is standard of care, embolization using 500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours, IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity compression devices, and early ambulation.
- In the interim analysis, the investigators will have 40 subjects in total with unequal randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35 subjects per arm for the final analysis (sum total N=140)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Drug: IV IbuprofenIbuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization |
| Intravenous acetaminophen | Experimental | Drug: IV AcetaminophenAcetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization |
| IV ibuprofen/IV acetaminophen | Experimental | Drug: IV Ibuprofen, Drug: IV AcetaminophenIbuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization |
| Intravenous placebo/Intravenous placebo | Active comparator | Drug: Intravenous placebo/Intravenous placeboSaline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients being considered for UFE including bleeding and/or bulk symptoms.
- Women of all ethnicities
- Ages 21-60
Key exclusion criteria (12 listed)
- Patients with current malignancy receiving treatment
- Women who are pregnant
- Cognitive impairment
- Clinically significant kidney disease
- Clinically significant liver disease
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 |
|---|---|---|
| IV IbuprofenAlso: Uterine artery embolizationUterine fibroid embolization | Drug | IV ibuprofen/IV acetaminophen, Intravenous Ibuprofen |
| IV AcetaminophenAlso: Uterine artery embolizationUterine fibroid embolization | Drug | IV ibuprofen/IV acetaminophen, Intravenous acetaminophen |
| Intravenous placebo/Intravenous placeboAlso: Uterine artery embolizationUterine fibroid embolization | Drug | Intravenous placebo/Intravenous placebo |
Primary outcome
Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Time frame: 24 hours
Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
Time frame: 24 hours
Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.
4 secondary outcomes
Mean Nausea Intensity
Time frame: 24 hours
Opioid Consumption
Time frame: 24 hours
Anti-Emetic Consumption
Time frame: 24 hours
Maximum Nausea Intensity
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Symptomatic Uterine Fibroids and Adenomyosis
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
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.
Cheryl H Hoffman, MD principal investigator
University of California, Los Angeles
Jonathan S Jahr, MD principal investigator
University of California, Los Angeles
2 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 IV Ibuprofen and IV Acetaminophen in people with Symptomatic Uterine Fibroids and Adenomyosis, run by University of California, Los Angeles at 2 sites in United States.
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 3 inclusion and 12 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2018). 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?
Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen (time frame: 24 hours). 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 8 Jun 2018.