Postoperative PainNCT02605187
Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
A study testing No choice given, Choice given and Ibuprofen in people with Postoperative Pain, run by Stanford University at 1 site in United States.
Trial summary
The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- No choice given, Choice given and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 22 May 2017
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 18-50
- Singleton gestation
- Not in active labor
- Scheduled for their 1st, 2nd, or 3rd elective Cesarean
- Cesarean deliveries under spinal or combined spinal epidural anesthesia (with no additional epidural doses administered)
Who cannot join
- History of chronic pain, anxiety, or depression
- Unable to understand the concept of Verbal Numerical Pain Scale at the time of informed consent
- Chronic consumption of opiates, antidepressants or anticonvulsants
- Intake of opioids, NSAIDS or acetaminophen 48hrs prior to the psychophysical test
- Preeclampsia (with any severe features)
- Diabetes (not controlled with diet and needing drugs)
- Preterm delivery (<35 weeks gestation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94305
About this study
The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patient's involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patient's preferences, needs and expectations.
Read the detailed description
This randomized, controlled study will include a simple, preoperative questionnaire to obtain baseline demographic and obstetric data; and complete questions (that have previously been shown to be predictive of postoperative pain) from which we will determine their expected and target postoperative pain scores. These questionnaires should take less than 3-4 minutes to complete.
The subject will then be randomized into "choice" and "no choice" groups. The randomization for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will get a choice for their analgesic protocol. All women will receive the same medications for intraoperative anesthetic management -- only the postoperative pain medications will be altered.
The no choice group will receive the current standard analgesic protocol: medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h.
The group with the choice will be offered 3 different protocols:
- low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery.
Women randomized to the "choice" group will select a protocol after being given a standard script explaining advantages and disadvantages of each protocol.
Drugs and doses utilized in the study are safe for postpartum women and within dose range routinely used at our and other institutions.
All breakthrough pain will be managed the same for all patients, and adequate analgesia will be available to treat post-operative pain.
Primary breakthrough rescue analgesic will be our standard oral opioid oxycodone managed using our current treatment algorithm. If pain 1-4 out of 10, 1 tablet (5 mg) will be offered, if pain >4 out of 10, 2 tablets (10 mg) will be offered PRN. Pain not responding to oral opioids will be offered IV morphine boluses or PCA as per standard treatment protocols. Additional analgesic options (e.g. TAP blocks) will also be available as per standard care.
Following standard Cesarean delivery, postoperative data will be collected (directly from patients and from the electronic medical record) by study investigators blinded to group assignment.
Outcome measures:
- Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours post-cesarean
- Overall daily pain score and its deviation from target and expected pain score will be determined at 0-24 and >24-48 hours study periods.
- Opioid use (oral and IV morphine) in the 0-24 and >24-48 hour study periods.
- Time to first analgesic for breakthrough pain (minutes from spinal)
- Side effect: Pruritus score (0-100), nausea score (0-100) and number of episodes of vomiting for the 0-24 and >24-48 hour post- operative periods
- Any treatment of pruritus and/or nausea/vomiting
- Satisfaction with postoperative analgesia score (0-100)
- Discharge time (hours/minutes from surgery end)
Telephone follow-up for pain score, opioid use, and functional recovery will be performed at 1 week, 1 month, 3 months and 6 months post-Cesarean. The telephonic questions will last 3-4 minutes
- Conditions
- Postoperative Pain
- Being tested
- No choice given, Choice given, Ibuprofen, Acetaminophen, Gabapentin
- Keywords
- cesarean, postoperative pain, patient choice
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No choice givenOther
Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Choice givenOther
Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
IbuprofenDrug
Ibuprofen 600mg po q6h
AcetaminophenDrug
Acetaminophen 650mg po q6h
GabapentinDrug
Gabapentin 600mg po one time within 1 hour of delivery
Morphine (low)Drug
Also called Low dose morphine
Intrathecal morphine dose 50mcg
Morphine (med)Drug
Also called Medium dose morphine
Intrathecal morphine dose 150mcg
Morphine (high)Drug
Also called High dose morphine
Intrathecal morphine 300mcg
| Study group | Role | What they receive |
|---|---|---|
| No choice | Active comparator | No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h Receives: Other: No choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (med) |
| Choice: low protocol | Experimental | Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h Receives: Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (low) |
| Choice: medium protocol | Experimental | Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h Receives: Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (med) |
| Choice: high protocol | Experimental | Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose Receives: Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Gabapentin; Drug: Morphine (high) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in the 0-48 Hour Study Periods.
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Measured: 0-24 and 24-48 hour postoperative periods
Pain Scores
Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.
Measured: 3, 6, 12, 24, 36 and 48 hours after delivery
Secondary outcomes (10)
Count of Participants Who Need Opioid Use
Count of participants who need opioid use through 48 hours after delivery.
Measured: 0-24 and 24-48 hours after delivery
Count of Participants With Presence of Pruritus
Count of participants with pruritus through 48 hours after delivery.
Measured: 0-24 and 24-48 hours after delivery
Pruritus Score at 24 and 48 After Delivery
Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching.
Measured: 24 and 48 hours following delivery
Count of Participants Who Need Medical Treatment of Pruritus
Count of participants who need medical treatment of pruritus during first 48 hours after delivery.
Measured: 0-24 and 24-48 hours after delivery
Counts of Participants With Presence of Nausea
Count of participants with nausea through 48 hours after delivery.
Measured: 0-48 hours after delivery
Nausea Score Score at 24 and 48 After Delivery
Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.
Measured: 0-24 and 24-48 hours after delivery
Counts of Participants Who Need Medical Treatment for Nausea
Counts of participants who need medical treatment of nausea through 48 hours after delivery.
Measured: 0-24 and 24-48 hours after delivery
Average Number of Vomiting Episodes After Delivery
Measured: 0-24 and 24-48 hours after delivery
Time to Discharge
Minutes from delivery until discharge.
Measured: Delivery through discharge (average 4 days)
Patient Overall Satisfaction With Postoperative Analgesia
Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.
Measured: 24 and 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion22 May 2017
- Study completion22 May 2017
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, MBBCh, MDCH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605187
- Sponsor's protocol ID
- 34740
- Status last verified
- Sep 2018
- First submitted
- 10 Nov 2015
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Eisenach JC, Pan P, Smiley RM, Lavand'homme P, Landau R, Houle TT. Resolution of pain after childbirth. Anesthesiology. 2013 Jan;118(1):143-51. doi: 10.1097/ALN.0b013e318278ccfd.
PubMed 23249931Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
PubMed 16960491Carvalho B, Sutton CD, Kowalczyk JJ, Flood PD. Impact of patient choice for different postcesarean delivery analgesic protocols on opioid consumption: a randomized prospective clinical trial. Reg Anesth Pain Med. 2019 May;44(5):578-585. doi: 10.1136/rapm-2018-100206. Epub 2019 Mar 13.
PubMed 30867278
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
- ClinicalTrials.gov ID
- NCT02605187
- Acronym / sponsor ID
- 34740
- Conditions
- Postoperative Pain
- Keywords
- cesarean, postoperative pain, patient choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 11 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 ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patient's involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patient's preferences, needs and expectations.
Detailed description
This randomized, controlled study will include a simple, preoperative questionnaire to obtain baseline demographic and obstetric data; and complete questions (that have previously been shown to be predictive of postoperative pain) from which we will determine their expected and target postoperative pain scores. These questionnaires should take less than 3-4 minutes to complete.
The subject will then be randomized into "choice" and "no choice" groups. The randomization for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will get a choice for their analgesic protocol. All women will receive the same medications for intraoperative anesthetic management -- only the postoperative pain medications will be altered.
The no choice group will receive the current standard analgesic protocol: medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h.
The group with the choice will be offered 3 different protocols:
- low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery.
Women randomized to the "choice" group will select a protocol after being given a standard script explaining advantages and disadvantages of each protocol.
Drugs and doses utilized in the study are safe for postpartum women and within dose range routinely used at our and other institutions.
All breakthrough pain will be managed the same for all patients, and adequate analgesia will be available to treat post-operative pain.
Primary breakthrough rescue analgesic will be our standard oral opioid oxycodone managed using our current treatment algorithm. If pain 1-4 out of 10, 1 tablet (5 mg) will be offered, if pain >4 out of 10, 2 tablets (10 mg) will be offered PRN. Pain not responding to oral opioids will be offered IV morphine boluses or PCA as per standard treatment protocols. Additional analgesic options (e.g. TAP blocks) will also be available as per standard care.
Following standard Cesarean delivery, postoperative data will be collected (directly from patients and from the electronic medical record) by study investigators blinded to group assignment.
Outcome measures:
- Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours post-cesarean
- Overall daily pain score and its deviation from target and expected pain score will be determined at 0-24 and >24-48 hours study periods.
- Opioid use (oral and IV morphine) in the 0-24 and >24-48 hour study periods.
- Time to first analgesic for breakthrough pain (minutes from spinal)
- Side effect: Pruritus score (0-100), nausea score (0-100) and number of episodes of vomiting for the 0-24 and >24-48 hour post- operative periods
- Any treatment of pruritus and/or nausea/vomiting
- Satisfaction with postoperative analgesia score (0-100)
- Discharge time (hours/minutes from surgery end)
Telephone follow-up for pain score, opioid use, and functional recovery will be performed at 1 week, 1 month, 3 months and 6 months post-Cesarean. The telephonic questions will last 3-4 minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No choice | Active comparator | Other: No choice given, Drug: Ibuprofen, Drug: Acetaminophen, Drug: Morphine (med)No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: low protocol | Experimental | Other: Choice given, Drug: Ibuprofen, Drug: Acetaminophen, Drug: Morphine (low)Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: medium protocol | Experimental | Other: Choice given, Drug: Ibuprofen, Drug: Acetaminophen, Drug: Morphine (med)Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: high protocol | Experimental | Other: Choice given, Drug: Ibuprofen, Drug: Acetaminophen, Drug: Gabapentin, Drug: Morphine (high)Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age 18-50
- Singleton gestation
- Not in active labor
- Scheduled for their 1st, 2nd, or 3rd elective Cesarean
- Cesarean deliveries under spinal or combined spinal epidural anesthesia (with no additional epidural doses administered)
Key exclusion criteria (7 listed)
- History of chronic pain, anxiety, or depression
- Unable to understand the concept of Verbal Numerical Pain Scale at the time of informed consent
- Chronic consumption of opiates, antidepressants or anticonvulsants
- Intake of opioids, NSAIDS or acetaminophen 48hrs prior to the psychophysical test
- Preeclampsia (with any severe features)
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 |
|---|---|---|
| No choice givenPatients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose. | Other | No choice |
| Choice givenPatients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select. | Other | Choice: high protocol, Choice: low protocol, Choice: medium protocol |
| IbuprofenIbuprofen 600mg po q6h | Drug | Choice: high protocol, Choice: low protocol, Choice: medium protocol, No choice |
| AcetaminophenAcetaminophen 650mg po q6h | Drug | Choice: high protocol, Choice: low protocol, Choice: medium protocol, No choice |
| GabapentinGabapentin 600mg po one time within 1 hour of delivery | Drug | Choice: high protocol |
| Morphine (low)Also: Low dose morphineIntrathecal morphine dose 50mcg | Drug | Choice: low protocol |
| Morphine (med)Also: Medium dose morphineIntrathecal morphine dose 150mcg | Drug | Choice: medium protocol, No choice |
| Morphine (high)Also: High dose morphineIntrathecal morphine 300mcg | Drug | Choice: high protocol |
Primary outcome
Opioid Consumption in the 0-48 Hour Study Periods.
Time frame: 0-24 and 24-48 hour postoperative periods
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Pain Scores
Time frame: 3, 6, 12, 24, 36 and 48 hours after delivery
Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.
10 secondary outcomes
Count of Participants Who Need Opioid Use
Time frame: 0-24 and 24-48 hours after delivery
Count of Participants With Presence of Pruritus
Time frame: 0-24 and 24-48 hours after delivery
Pruritus Score at 24 and 48 After Delivery
Time frame: 24 and 48 hours following delivery
Count of Participants Who Need Medical Treatment of Pruritus
Time frame: 0-24 and 24-48 hours after delivery
Counts of Participants With Presence of Nausea
Time frame: 0-48 hours after delivery
Nausea Score Score at 24 and 48 After Delivery
Time frame: 0-24 and 24-48 hours after delivery
Counts of Participants Who Need Medical Treatment for Nausea
Time frame: 0-24 and 24-48 hours after delivery
Average Number of Vomiting Episodes After Delivery
Time frame: 0-24 and 24-48 hours after delivery
Time to Discharge
Time frame: Delivery through discharge (average 4 days)
Patient Overall Satisfaction With Postoperative Analgesia
Time frame: 24 and 48 hours after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23249931Eisenach JC, Pan P, Smiley RM, Lavand'homme P, Landau R, Houle TT. Resolution of pain after childbirth. Anesthesiology. 2013 Jan;118(1):143-51. doi: 10.1097/ALN.0b013e318278ccfd.
- Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 16960491Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
- Derived from this study: PubMed 30867278Carvalho B, Sutton CD, Kowalczyk JJ, Flood PD. Impact of patient choice for different postcesarean delivery analgesic protocols on opioid consumption: a randomized prospective clinical trial. Reg Anesth Pain Med. 2019 May;44(5):578-585. doi: 10.1136/rapm-2018-100206. Epub 2019 Mar 13.
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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.
Brendan Carvalho, MBBCh, MDCH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No choice given, Choice given and Ibuprofen in people with Postoperative Pain, run by Stanford University at 1 site 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 5 inclusion and 7 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 16 Oct 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 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?
Opioid Consumption in the 0-48 Hour Study Periods. (time frame: 0-24 and 24-48 hour postoperative periods). 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?
On the ClinicalTrials.gov record for NCT02605187, which also lists 5 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 16 Oct 2018.