CancerPhase 4NCT03176199
A Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Patients With Moderate to Severe Cancer Pain
A Phase 4 study testing Oxycodone in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 4 sites in Taiwan.
Trial summary
This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe… Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Sep 2016to 31 Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients aged 20 years old and over
- Patients with background cancer pain more than or equal to NRS 4 during previous 24 hours, or receive more than or equal to 3 times/day for breakthrough pain medication management
- ECOG ≤ 2
- Opioid-naive patients who are not administrated any strong opioid for at least one month prior to the index treatments, who currently with poor pain control and intended to be treated for pain relief with strong opioids. The FDA identifies opioid-naive as who not receiving the following treatment for a week or longer of strong opioids:
- 1) ≥ 60 mg of morphine daily 2) ≥25 mcg transdermalfentanyl/hour 3) ≥ 8 mg of oral hydromorphone daily or 4) an equianalgesic dose of another opioid
- 5) Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study
- 6) Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti-tumor therapy prior to randomization.
- 7) Patients or his/her caregivers who are able to fill out the diary and questionnaire forms
Who cannot join
- Patients diagnosed with non-cancer pain or unexplained pain
- Patients suffered with post-op pain
- Patients who cannot be applicable for oral administration
- Patients who have severe constipation defined by CTCAE grade 3 and above
- Patients with any disease that may easily lead to respiratory depression
- Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization
Show all 13Show fewer
- There are abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade
- Patients who have potential risk for surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction; or patient is unable to effectively absorb oral medication through gastrointestinal tract
- Patients who are drug or alcohol abuse
- Patients with moderate to severe psychiatric problems
- Patients who have hypersensitivity to oxycodone
- Patients who are pregnant or lactating
- Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Changhua Christian Hospital
Chang-hua, 500
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain
This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.
Read the detailed description
This is an interventional, open label, randomized controlled study carrying in multi-centers. Eighty opioid-naive patients with moderate to severe cancer pain (≥ 4) in outpatient department (OPD), who agreed and signed informed consent will be randomly assigned in a 1:1 ratio to receive CR + IR oxycodone or conventional IR oxycodone groups. The study is to compare the titration efficacy and safety of CR with IR oxycodone (experimental group) comparing IR oxycodone (control group) in cancer patients suffered with moderate to severe pain. The study last 14 days. Patients begin the study by the first day visit of the clinic and received the study medication (Baseline). Following visits on cycle 1 (day 3 or 4 depends on the available clinics), cycle 2 (day 7±1), cycle 3 (day 10±1), and cycle 4 (day 14±1). In the experimental group, 10 mg CR oxycodone tablet will be selected as background dose of titration, and patients will be administered once every 12 hrs. Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. In the control group, the conventional titration with IR oxycodone will be conducted according to pain intensity, using 5 mg as initial dose, e.g. 12 capsules of 5mg IR oxycodone (giving in Q6H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for rescue use upon to the first cycle. Patient will record their pain score (4 times in Q6H frequency and before taking the drug), 24hr total dose (total tablets/capsule number), number of breakthrough pain and PRN time and dosage used onto the patient diary. The background dose of each patient will be titrated after cycle 1 by investigators. Titration cycles will be recorded and evaluated pain assessments on cycle 2 (day 7±1), cycle 3 (Day 10±1), cycle 4 (day 14±1). During study, the study nurse will follow patient's daily records, drug use condition every second day by telephone or other contact methods to keep close monitor of patient's condition. The telephone contact for cycle 1 and cycle 3 is acceptable for this study. If the telephone contact is conducted for patient, the 1-week quantities of oxycodone should be dispensed to patient.
The safety for individual patient will be followed during study up to end of treatment (EOT) or early termination (ET). All adverse events (AE(s)) and serious adverse events (SAE(s)) occurred during the study period will be followed until resolution or the event is considered stable.
- Being tested
- Oxycodone
- Keywords
- control-released oxycodone, immediate-released oxycodone, cancer pain, opioid-naive
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Every 12 hours for control-released oxycodone (OxyContin®)
OxycodoneDrug
Every 6 hours for immediate-released oxycodone (OxyNorm®)
| Study group | Role | What they receive |
|---|---|---|
| Control-released oxycodone | Experimental | Control-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN Receives: Drug: Oxycodone |
| Immediate-released oxycodone | Active comparator | Immediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment
The change from baseline of NRS pain score and the daily number of breakthrough pain
Measured: Up to 14 days
Secondary outcomes (7)
To evaluate the percentage of patients in each titration cycle
The percentage of patients in each titration cycle
Measured: Up to 14 days
To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Measured: Up to 14 days
The total opioid taken within 24hrs daily from baseline to day 14
The total opioid taken within 24 hrs daily from baseline to day 14
Measured: Up to 14 days
To evaluate the mean daily NRS score of subjects from baseline to day 14
Mean daily NRS score of patients from baseline to day 14
Measured: Up to 14 days
To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
The total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
Measured: Up to 14 days
To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient
The occurrence rate of adverse events and physical examination status
Measured: Up to 28 days
To evaluate the change from baseline in questionnaire
The change from baseline in questionnaire
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Sep 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chih-Jen Hung, MSc, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176199
- Sponsor's protocol ID
- OXY15-TW-401
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mercadante S, Porzio G, Ferrera P, Fulfaro F, Aielli F, Ficorella C, Verna L, Tirelli W, Villari P, Arcuri E. Low morphine doses in opioid-naive cancer patients with pain. J Pain Symptom Manage. 2006 Mar;31(3):242-7. doi: 10.1016/j.jpainsymman.2006.01.001.
PubMed 16563318Mercadante S. Opioid titration in cancer pain: a critical review. Eur J Pain. 2007 Nov;11(8):823-30. doi: 10.1016/j.ejpain.2007.01.003. Epub 2007 Feb 28.
PubMed 17331764Klepstad P, Kaasa S, Jystad A, Hval B, Borchgrevink PC. Immediate- or sustained-release morphine for dose finding during start of morphine to cancer patients: a randomized, double-blind trial. Pain. 2003 Jan;101(1-2):193-8. doi: 10.1016/s0304-3959(02)00328-7.
PubMed 12507714Ripamonti CI, Santini D, Maranzano E, Berti M, Roila F; ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol. 2012 Oct;23 Suppl 7:vii139-54. doi: 10.1093/annonc/mds233. No abstract available.
PubMed 22997447Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, Dale O, De Conno F, Fallon M, Hanna M, Haugen DF, Juhl G, King S, Klepstad P, Laugsand EA, Maltoni M, Mercadante S, Nabal M, Pigni A, Radbruch L, Reid C, Sjogren P, Stone PC, Tassinari D, Zeppetella G; European Palliative Care Research Collaborative (EPCRC); European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012 Feb;13(2):e58-68. doi: 10.1016/S1470-2045(12)70040-2.
PubMed 22300860Pan H, Zhang Z, Zhang Y, Xu N, Lu L, Dou C, Guo Y, Wu S, Yue J, Wu D, Dai Y. Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain. Clin Drug Investig. 2007;27(4):259-67. doi: 10.2165/00044011-200727040-00005.
PubMed 17358098Salzman RT, Roberts MS, Wild J, Fabian C, Reder RF, Goldenheim PD. Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999 Oct;18(4):271-9. doi: 10.1016/s0885-3924(99)00079-2.
PubMed 10534967
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain
- ClinicalTrials.gov ID
- NCT03176199
- Acronym / sponsor ID
- OXY15-TW-401
- Keywords
- control-released oxycodone, immediate-released oxycodone, cancer pain, opioid-naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jun 2017 (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.
This study is to evaluate the efficacy and safety of a titration method by selects 10 mg control-released (CR) oxycodone tablet as background drug in combined with immediate-released (IR) oxycodone, compared to conventional titration method with immediate-released (IR) oxycodone in patients with moderate to severe cancer pain in Taiwan.
Detailed description
This is an interventional, open label, randomized controlled study carrying in multi-centers. Eighty opioid-naive patients with moderate to severe cancer pain (≥ 4) in outpatient department (OPD), who agreed and signed informed consent will be randomly assigned in a 1:1 ratio to receive CR + IR oxycodone or conventional IR oxycodone groups. The study is to compare the titration efficacy and safety of CR with IR oxycodone (experimental group) comparing IR oxycodone (control group) in cancer patients suffered with moderate to severe pain. The study last 14 days. Patients begin the study by the first day visit of the clinic and received the study medication (Baseline). Following visits on cycle 1 (day 3 or 4 depends on the available clinics), cycle 2 (day 7±1), cycle 3 (day 10±1), and cycle 4 (day 14±1). In the experimental group, 10 mg CR oxycodone tablet will be selected as background dose of titration, and patients will be administered once every 12 hrs. Meanwhile, the titration with IR oxycodone will be added according to the pain intensity, e.g. if patient receiving 6 tablets of 10 mg CR oxycodone (giving in Q12H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for managing acute pain (rescue use) for the first cycle. In the control group, the conventional titration with IR oxycodone will be conducted according to pain intensity, using 5 mg as initial dose, e.g. 12 capsules of 5mg IR oxycodone (giving in Q6H frequency for 3 days), 12 capsules of 5mg IR oxycodone will be dispensed for rescue use upon to the first cycle. Patient will record their pain score (4 times in Q6H frequency and before taking the drug), 24hr total dose (total tablets/capsule number), number of breakthrough pain and PRN time and dosage used onto the patient diary. The background dose of each patient will be titrated after cycle 1 by investigators. Titration cycles will be recorded and evaluated pain assessments on cycle 2 (day 7±1), cycle 3 (Day 10±1), cycle 4 (day 14±1). During study, the study nurse will follow patient's daily records, drug use condition every second day by telephone or other contact methods to keep close monitor of patient's condition. The telephone contact for cycle 1 and cycle 3 is acceptable for this study. If the telephone contact is conducted for patient, the 1-week quantities of oxycodone should be dispensed to patient.
The safety for individual patient will be followed during study up to end of treatment (EOT) or early termination (ET). All adverse events (AE(s)) and serious adverse events (SAE(s)) occurred during the study period will be followed until resolution or the event is considered stable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-released oxycodone | Experimental | Drug: OxycodoneControl-released oxycodone Q12H, initial daily dose is 20 mg + immediate-released oxycodone for PRN |
| Immediate-released oxycodone | Active comparator | Drug: OxycodoneImmediate-released oxycodone Q6H, initial daily dose is 20mg + immediate-released oxycodone for PRN |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer patients aged 20 years old and over
- Patients with background cancer pain more than or equal to NRS 4 during previous 24 hours, or receive more than or equal to 3 times/day for breakthrough pain medication management
- ECOG ≤ 2
- Opioid-naive patients who are not administrated any strong opioid for at least one month prior to the index treatments, who currently with poor pain control and intended to be treated for pain relief with strong opioids. The FDA identifies opioid-naive as who not receiving the following treatment for a week or longer of strong opioids:
- 1) ≥ 60 mg of morphine daily 2) ≥25 mcg transdermalfentanyl/hour 3) ≥ 8 mg of oral hydromorphone daily or 4) an equianalgesic dose of another opioid
Key exclusion criteria (13 listed)
- Patients diagnosed with non-cancer pain or unexplained pain
- Patients suffered with post-op pain
- Patients who cannot be applicable for oral administration
- Patients who have severe constipation defined by CTCAE grade 3 and above
- Patients with any disease that may easily lead to respiratory depression
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 |
|---|---|---|
| OxycodoneEvery 12 hours for control-released oxycodone (OxyContin®) | Drug | Control-released oxycodone |
| OxycodoneEvery 6 hours for immediate-released oxycodone (OxyNorm®) | Drug | Immediate-released oxycodone |
Primary outcome
To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment
Time frame: Up to 14 days
The change from baseline of NRS pain score and the daily number of breakthrough pain
7 secondary outcomes
To evaluate the percentage of patients in each titration cycle
Time frame: Up to 14 days
To evaluate the number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Time frame: Up to 14 days
The total opioid taken within 24hrs daily from baseline to day 14
Time frame: Up to 14 days
To evaluate the mean daily NRS score of subjects from baseline to day 14
Time frame: Up to 14 days
To evaluate the total daily rescue dose taken (immediate-released oxycodone capsule) for treatment of breakthrough pain among patients from baseline to day 14
Time frame: Up to 14 days
To evaluate the tolerability and safety of Oxycodone CR and IR in cancer pain patient
Time frame: Up to 28 days
To evaluate the change from baseline in questionnaire
Time frame: Up to 14 days
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 18 Mar 2020.
- Background: PubMed 16563318Mercadante S, Porzio G, Ferrera P, Fulfaro F, Aielli F, Ficorella C, Verna L, Tirelli W, Villari P, Arcuri E. Low morphine doses in opioid-naive cancer patients with pain. J Pain Symptom Manage. 2006 Mar;31(3):242-7. doi: 10.1016/j.jpainsymman.2006.01.001.
- Background: PubMed 17331764Mercadante S. Opioid titration in cancer pain: a critical review. Eur J Pain. 2007 Nov;11(8):823-30. doi: 10.1016/j.ejpain.2007.01.003. Epub 2007 Feb 28.
- Background: PubMed 12507714Klepstad P, Kaasa S, Jystad A, Hval B, Borchgrevink PC. Immediate- or sustained-release morphine for dose finding during start of morphine to cancer patients: a randomized, double-blind trial. Pain. 2003 Jan;101(1-2):193-8. doi: 10.1016/s0304-3959(02)00328-7.
- Background: PubMed 22997447Ripamonti CI, Santini D, Maranzano E, Berti M, Roila F; ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol. 2012 Oct;23 Suppl 7:vii139-54. doi: 10.1093/annonc/mds233. No abstract available.
- Background: PubMed 22300860Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, Dale O, De Conno F, Fallon M, Hanna M, Haugen DF, Juhl G, King S, Klepstad P, Laugsand EA, Maltoni M, Mercadante S, Nabal M, Pigni A, Radbruch L, Reid C, Sjogren P, Stone PC, Tassinari D, Zeppetella G; European Palliative Care Research Collaborative (EPCRC); European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol. 2012 Feb;13(2):e58-68. doi: 10.1016/S1470-2045(12)70040-2.
- Background: PubMed 17358098Pan H, Zhang Z, Zhang Y, Xu N, Lu L, Dou C, Guo Y, Wu S, Yue J, Wu D, Dai Y. Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain. Clin Drug Investig. 2007;27(4):259-67. doi: 10.2165/00044011-200727040-00005.
- Background: PubMed 10534967Salzman RT, Roberts MS, Wild J, Fabian C, Reder RF, Goldenheim PD. Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999 Oct;18(4):271-9. doi: 10.1016/s0885-3924(99)00079-2.
- Individual participant dataSharing planned: Undecided
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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.
Chih-Jen Hung, MSc principal investigator
Taichung Veterans General Hospital
4 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 Oxycodone in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 4 sites in Taiwan.
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 8 inclusion and 13 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
To evaluate the variable change of NRS pain score and the number of breakthrough pain to obtain pain control after treatment (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176199, which also lists 7 linked publications.
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 18 Mar 2020.