Pain, PostoperativePhase 4NCT03648008
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
A Phase 4 study testing Hydromorphone and Morphine in people with Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative, Thoracic Surgery, Video-Assisted
- What is being tested?
- Hydromorphone and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2018to 1 Sep 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
- 70≥ Age ≥18
- Selective operation lung section with video-assisted thoracic surgery (VATS)
- III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
- Patients informed and agreed to join the study
Who cannot join
- Abnormal function of liver and kidney
- Allergic- dependence history of alcohol, opioids and Local anesthetics
- No noncompliance
- Mental disease history，language communication disorder，cicatricial diathesis
- Underweight or overweight（BMI<18 or >30)
- Patients not suitable for clinical subjects for other reasons
Show all 9Show fewer
- Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
- History of previous abnormal anaesthesia
- Women during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).
- Being tested
- Hydromorphone, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.
MorphineDrug
0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1 Receives: Drug: Morphine |
| Group NBH | Experimental | Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1 Receives: Drug: Hydromorphone |
| Group BH | Experimental | Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1 Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest pain assessment at 0.5 hour after tracheal extubation
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 0.5 hour after tracheal extubation
Rest pain assessment at 8 p.m. surgery day
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at surgery day
Activity pain assessment at 8 p.m. surgery day
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at surgery day
Rest pain assessment at 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at first day after surgery
Activity pain assessment at 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at first day after surgery
Rest pain assessment at 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at first day after surgery
Activity pain assessment at 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at first day after surgery
Rest pain assessment at 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at second day after surgery
Activity pain assessment at 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at second day after surgery
Rest pain assessment at 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at second day after surgery
Activity pain assessment at 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at second day after surgery
Rest pain assessment at 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at third day after surgery
Activity pain assessment at 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 a.m. at third day after surgery
Rest pain assessment at 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at third day after surgery
Activity pain assessment at 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Measured: 8 p.m. at third day after surgery
Secondary outcomes (27)
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 p.m. at surgery day
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 p.m. at surgery day
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 a.m. at first day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 a.m. at first day after surgery
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 p.m. at first day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 p.m. at first day after surgery
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 a.m. at second day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 a.m. at second day after surgery
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 p.m. at second day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 p.m. at second day after surgery
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 a.m. at third day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 a.m. at third day after surgery
Ratio of Nausea
Record whether patients experience nausea
Measured: 8 p.m. at third day after surgery
Ratio of Vomiting
Record whether patients experience vomiting and how many times do they experience
Measured: 8 p.m. at third day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump
Measured: 8 p.m. at surgery day
Total Antiemetic usage
Sum up any antiemetic
Measured: 8 p.m. at surgery day
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 a.m. at first day after surgery
Total Antiemetic usage
Sum up any antiemetic from last time point
Measured: 8 p.m. at first day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 p.m. at first day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 a.m. at second day after surgery
Total Antiemetic usage
Sum up any antiemetic from last time point
Measured: 8 a.m. at second day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 p.m. at second day after surgery
Total Antiemetic usage
Sum up any antiemetic from last time point
Measured: 8 p.m. at second day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 a.m. at third day after surgery
Total Antiemetic usage
Sum up any antiemetic from last time point
Measured: 8 a.m. at third day after surgery
Total Analgesia usage
Sum up any extra analgesia when analgesic failure (VAS persistently > 4) with PCIA pump from last time point
Measured: 8 p.m. at third day after surgery
Total Antiemetic usage
Sum up any antiemetic from last time point
Measured: 8 p.m. at third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start5 May 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648008
- Sponsor's protocol ID
- 2018-014
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
- ClinicalTrials.gov ID
- NCT03648008
- Acronym / sponsor ID
- 2018-014
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 27 Aug 2018 (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.
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: MorphineDrug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1 |
| Group NBH | Experimental | Drug: HydromorphoneDrug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1 |
| Group BH | Experimental | Drug: HydromorphoneDrug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 70≥ Age ≥18
- Selective operation lung section with video-assisted thoracic surgery (VATS)
- III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
- Patients informed and agreed to join the study
Key exclusion criteria (9 listed)
- Abnormal function of liver and kidney
- Allergic- dependence history of alcohol, opioids and Local anesthetics
- No noncompliance
- Mental disease history，language communication disorder，cicatricial diathesis
- Underweight or overweight（BMI<18 or >30)
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 |
|---|---|---|
| Hydromorphone0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump. | Drug | Group BH, Group NBH |
| Morphine0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump. | Drug | Group M |
Primary outcome
Rest pain assessment at 0.5 hour after tracheal extubation
Time frame: 0.5 hour after tracheal extubation
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. surgery day
Time frame: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. surgery day
Time frame: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 a.m. at first day after surgery
Time frame: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at first day after surgery
Time frame: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at first day after surgery
Time frame: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at first day after surgery
Time frame: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 a.m. at second day after surgery
Time frame: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at second day after surgery
Time frame: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at second day after surgery
Time frame: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at second day after surgery
Time frame: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 a.m. at third day after surgery
Time frame: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at third day after surgery
Time frame: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at third day after surgery
Time frame: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at third day after surgery
Time frame: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
27 secondary outcomes
Ratio of Nausea
Time frame: 8 p.m. at surgery day
Ratio of Vomiting
Time frame: 8 p.m. at surgery day
Ratio of Nausea
Time frame: 8 a.m. at first day after surgery
Ratio of Vomiting
Time frame: 8 a.m. at first day after surgery
Ratio of Nausea
Time frame: 8 p.m. at first day after surgery
Ratio of Vomiting
Time frame: 8 p.m. at first day after surgery
Ratio of Nausea
Time frame: 8 a.m. at second day after surgery
Ratio of Vomiting
Time frame: 8 a.m. at second day after surgery
Ratio of Nausea
Time frame: 8 p.m. at second day after surgery
Ratio of Vomiting
Time frame: 8 p.m. at second day after surgery
Ratio of Nausea
Time frame: 8 a.m. at third day after surgery
Ratio of Vomiting
Time frame: 8 a.m. at third day after surgery
Ratio of Nausea
Time frame: 8 p.m. at third day after surgery
Ratio of Vomiting
Time frame: 8 p.m. at third day after surgery
Total Analgesia usage
Time frame: 8 p.m. at surgery day
Total Antiemetic usage
Time frame: 8 p.m. at surgery day
Total Analgesia usage
Time frame: 8 a.m. at first day after surgery
Total Antiemetic usage
Time frame: 8 p.m. at first day after surgery
Total Analgesia usage
Time frame: 8 p.m. at first day after surgery
Total Analgesia usage
Time frame: 8 a.m. at second day after surgery
Total Antiemetic usage
Time frame: 8 a.m. at second day after surgery
Total Analgesia usage
Time frame: 8 p.m. at second day after surgery
Total Antiemetic usage
Time frame: 8 p.m. at second day after surgery
Total Analgesia usage
Time frame: 8 a.m. at third day after surgery
Total Antiemetic usage
Time frame: 8 a.m. at third day after surgery
Total Analgesia usage
Time frame: 8 p.m. at third day after surgery
Total Antiemetic usage
Time frame: 8 p.m. at third day after surgery
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 26 Sep 2018.
- 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.
Min Yan, Doctor study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone and Morphine in people with Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 9 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 26 Sep 2018. 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 China. 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 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?
Rest pain assessment at 0.5 hour after tracheal extubation (time frame: 0.5 hour after tracheal extubation). The study lists 15 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 26 Sep 2018.