Postoperative PainPhase 3NCT02145975
Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine
A Phase 3 study testing Fentanyl and Morphine in people with Postoperative Pain, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2014to May 2014
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients physical status I and IV, 18-65 years of age
- Patients scheduled for surgery under general or regional anesthesia and fasting as defined in the fasting guidelines.
- Patients whose accept and sign the informed consent of study.
Who cannot join
- Patients with severe respiratory depression given by a monitoring state indicating hypoxemia (oxyhemoglobin saturation below 90 %).
- Patients with immediate postoperative hemodynamic instability given by bradycardia , hypotension or hypoperfusion states observed by clinical paleness, active bleeding, altered sensorium, and altered alertness not explained by effects of anesthetics .
- Neurological disorders such as metabolic basis psychiatric disorders, mental retardation, congenital neurodegenerative conditions, hypoxic or ischemic related to aging that do not allow adequate evaluation of the analog scale pain assessment.
- Patients with a history of tolerance to opioids for chronic use, which is defined to a period of 2 weeks.
- Patients who have undergone epidural analgesia protocols, neuraxial and peripheral nerve blocks.
- Patients with any alteration in neurological status. History of psychiatric disorders. Patient with known hypersensitivity or allergic reactions to opioids. Women who are pregnant or suspected to be.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine: a Randomized Parallel-group, Double-blind Clinical Trial
Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . In the literature there is no study that corroborates this theoretical assumption and proposes to compare which has fewer adverse effects. This drug produces effects similar to those reported for morphine but less magnitude and has the advantage that during the postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort and physical dependence are manifested in a significantly less degree.
Trying to solve the management of postoperative pain relief , our objective is to determine by controlled clinical trial of superiority if in adult patients undergoing surgery , fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia care unit compared to morphine.
Read the detailed description
Postoperative pain is a severe problem of high incidence worldwide. According to a systematic review of the literature by Dolin et al , the incidence of moderate to severe postoperative pain in 41% of patients were found , and of these , only 23% experienced relief of the same ( 1). International Association for Study of Pain defines pain as unpleasant sensory or emotional experience associated with actual or potential damage , or described in terms of such damage ( 3). The postoperative pain is not only important for to cause suffering or unpleasant experience to the patient, but also by involving harmful effects to the body ( 4). Thus, the secondary stress to pain triggers the release of a series of hormonal mediators and activation of the sympathetic nervous system in conjunction with surgical trauma and previous comorbidities of the patient, that cause dysfunction of multiple organ systems , including the cardiovascular (5, 6) , GI (7-10) and respiratory ( 11,12 ), among others , increasing the incidence of postoperative complications such as myocardial ischemia , atelectasis ( 25-75 % after abdominal surgery) , respiratory infections (pneumonia 1-3 % after cardiac surgery ) , ileus , deep vein thrombosis and cognitive dysfunction. Thus increases the morbidity and patient recovery is delayed. (5) Similarly it has been observed that postoperative pain increases stay in the post anesthesia care unit , readmission for pain management, and delayed rehabilitation and reintegration of patients to activities of daily living , with the consequent increase in costs (5) . Considering the above arguments , it is obvious that timely intervention generates profit problem on multiple levels.
While the management of postoperative pain should include issues ranging from education to the patient prior to its analgesic plan to late recovery period in the post-anesthesia care area is crucial. This is because it has been shown that poor control of postoperative pain ( 3) in the early hours is associated with higher levels of pain at 48 hours . There is growing interest in the question of why , despite the availability of different drugs and technological advances that allow a better understanding of the pathophysiology of pain , has not been achieved a greater impact on the incidence of this problem ( 13).
Opioids are the most important drugs for postoperative pain control. In the post-anesthesia care area , especially when faced with a patient with severe or unbearable pain (14,15) , the analgesic opioid titration is the most effective strategy for controlling postoperative pain ( 16). The most studied and used today opioid is morphine, which by its pharmacokinetic characteristics provides an important balance between speed of onset and maintenance of analgesia ( 17). However, there are other alternatives for analgesic titration , such as fentanyl , which has favorable pharmacokinetics to have a faster response and thus may shorten the time needed to decrease pain from severe to mild ( 14,15). There are comparative studies between fixed-dose fentanyl and morphine in the emergency services and some preliminary tests in the recovery area (18,19). The most recent of analgesic titration trials comparing appropriate doses of opioids to patient weight which would improve its efficacy and safety ( 20). The tests that are known to have used fentanyl and morphine compared fixed-dose and 10 minute intervals .
Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . In the literature there is no study that corroborates this theoretical assumption and proposes to compare which has fewer adverse effects. This drug produces effects similar to those reported for morphine but less magnitude and has the advantage that during the postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort and physical dependence are manifested in a significantly less degree.
Trying to solve the management of postoperative pain relief , our objective is to determine by controlled clinical trial of superiority if in adult patients undergoing surgery , fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia care unit compared to morphine.
- Conditions
- Postoperative Pain
- Keywords
- Severe postoperative pain, Morphine, Fentanyl, Time to titration of pain, Pain and PACU, Anesthesiology
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Opioids
The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.
MorphineDrug
Also called Opioids
The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Procedure: Fentanyl for rescue of acute postoperative pain in the postanesthesia care unit
Intervention:
The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. Receives: Drug: Fentanyl |
| Morphine | Active comparator | Procedure: Morphine for rescue of acute postoperative pain in the postanesthesia care unit
Intervention:
The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in minutes of titration of fentanyl and morphine in reducing severe postoperative pain to mild pain
Time in minutes of titration of fentanyl and morphine in reducing postoperative pain severe to mild pain with visual analog scale (≤ 3).
Measured: The outcome will be measured from the patient presents severe pain at the PACU until the time that presents mild pain and he does not need more rescue bolus assessed up to 4 hours
Secondary outcomes (4)
Stay time of patients in the postanesthetic recovery unit in hours.
Stay time of patients in the postanesthetic recovery unit in hours.
Measured: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room assessed up to 4 hours.
Satisfaction with the analgesic management
Satisfaction with the analgesic management received by the Likert scale in both groups at the time and 24 hours.
Measured: This outcome will be measured in the first hour at the PACU and postoperative 24 hours
Cumulative dosis
Cumulative dose of fentanyl vs morphine required for relief of pain in both groups.
Measured: The outcome will be measured from the patient experiences severe pain at the PACU and is given the first bolus rescue analgesic until is given last bolus rescue analgesic, assessed up to 4 hours
Saturation of oxygen and arterial pressure
O2 saturation and MAP in both groups every 5 minutes during the titration period.
Measured: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room, assessed up to 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Lucia Giraldo Salazar, Universidad de Antioquia
- Investigators
- Adriana Cadavid, MD, Principal investigator, Antioquia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145975
- Sponsor's protocol ID
- UDEAFEN001
- Status last verified
- May 2014
- First submitted
- 18 May 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fentanyl to Reduce the Time of Severe Postoperative Pain Relief Compared to Morphine: a Randomized Parallel-group, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02145975
- Acronym / sponsor ID
- UDEAFEN001
- Conditions
- Postoperative Pain
- Keywords
- Severe postoperative pain, Morphine, Fentanyl, Time to titration of pain, Pain and PACU, Anesthesiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- 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.
Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . In the literature there is no study that corroborates this theoretical assumption and proposes to compare which has fewer adverse effects. This drug produces effects similar to those reported for morphine but less magnitude and has the advantage that during the postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort and physical dependence are manifested in a significantly less degree.
Trying to solve the management of postoperative pain relief , our objective is to determine by controlled clinical trial of superiority if in adult patients undergoing surgery , fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia care unit compared to morphine.
Detailed description
Postoperative pain is a severe problem of high incidence worldwide. According to a systematic review of the literature by Dolin et al , the incidence of moderate to severe postoperative pain in 41% of patients were found , and of these , only 23% experienced relief of the same ( 1). International Association for Study of Pain defines pain as unpleasant sensory or emotional experience associated with actual or potential damage , or described in terms of such damage ( 3). The postoperative pain is not only important for to cause suffering or unpleasant experience to the patient, but also by involving harmful effects to the body ( 4). Thus, the secondary stress to pain triggers the release of a series of hormonal mediators and activation of the sympathetic nervous system in conjunction with surgical trauma and previous comorbidities of the patient, that cause dysfunction of multiple organ systems , including the cardiovascular (5, 6) , GI (7-10) and respiratory ( 11,12 ), among others , increasing the incidence of postoperative complications such as myocardial ischemia , atelectasis ( 25-75 % after abdominal surgery) , respiratory infections (pneumonia 1-3 % after cardiac surgery ) , ileus , deep vein thrombosis and cognitive dysfunction. Thus increases the morbidity and patient recovery is delayed. (5) Similarly it has been observed that postoperative pain increases stay in the post anesthesia care unit , readmission for pain management, and delayed rehabilitation and reintegration of patients to activities of daily living , with the consequent increase in costs (5) . Considering the above arguments , it is obvious that timely intervention generates profit problem on multiple levels.
While the management of postoperative pain should include issues ranging from education to the patient prior to its analgesic plan to late recovery period in the post-anesthesia care area is crucial. This is because it has been shown that poor control of postoperative pain ( 3) in the early hours is associated with higher levels of pain at 48 hours . There is growing interest in the question of why , despite the availability of different drugs and technological advances that allow a better understanding of the pathophysiology of pain , has not been achieved a greater impact on the incidence of this problem ( 13).
Opioids are the most important drugs for postoperative pain control. In the post-anesthesia care area , especially when faced with a patient with severe or unbearable pain (14,15) , the analgesic opioid titration is the most effective strategy for controlling postoperative pain ( 16). The most studied and used today opioid is morphine, which by its pharmacokinetic characteristics provides an important balance between speed of onset and maintenance of analgesia ( 17). However, there are other alternatives for analgesic titration , such as fentanyl , which has favorable pharmacokinetics to have a faster response and thus may shorten the time needed to decrease pain from severe to mild ( 14,15). There are comparative studies between fixed-dose fentanyl and morphine in the emergency services and some preliminary tests in the recovery area (18,19). The most recent of analgesic titration trials comparing appropriate doses of opioids to patient weight which would improve its efficacy and safety ( 20). The tests that are known to have used fentanyl and morphine compared fixed-dose and 10 minute intervals .
Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in severe acute postoperative pain acts faster than its congener (morphine ) for pain relief . In the literature there is no study that corroborates this theoretical assumption and proposes to compare which has fewer adverse effects. This drug produces effects similar to those reported for morphine but less magnitude and has the advantage that during the postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort and physical dependence are manifested in a significantly less degree.
Trying to solve the management of postoperative pain relief , our objective is to determine by controlled clinical trial of superiority if in adult patients undergoing surgery , fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia care unit compared to morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: FentanylProcedure: Fentanyl for rescue of acute postoperative pain in the postanesthesia care unit Intervention: The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. |
| Morphine | Active comparator | Drug: MorphineProcedure: Morphine for rescue of acute postoperative pain in the postanesthesia care unit Intervention: The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients physical status I and IV, 18-65 years of age
- Patients scheduled for surgery under general or regional anesthesia and fasting as defined in the fasting guidelines.
- Patients whose accept and sign the informed consent of study.
Key exclusion criteria (6 listed)
- Patients with severe respiratory depression given by a monitoring state indicating hypoxemia (oxyhemoglobin saturation below 90 %).
- Patients with immediate postoperative hemodynamic instability given by bradycardia , hypotension or hypoperfusion states observed by clinical paleness, active bleeding, altered sensorium, and altered alertness not explained by effects of anesthetics .
- Neurological disorders such as metabolic basis psychiatric disorders, mental retardation, congenital neurodegenerative conditions, hypoxic or ischemic related to aging that do not allow adequate evaluation of the analog scale pain assessment.
- Patients with a history of tolerance to opioids for chronic use, which is defined to a period of 2 weeks.
- Patients who have undergone epidural analgesia protocols, neuraxial and peripheral nerve blocks.
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 |
|---|---|---|
| FentanylAlso: OpioidsThe nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. | Drug | Fentanyl |
| MorphineAlso: OpioidsThe nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized. | Drug | Morphine |
Primary outcome
Time in minutes of titration of fentanyl and morphine in reducing severe postoperative pain to mild pain
Time frame: The outcome will be measured from the patient presents severe pain at the PACU until the time that presents mild pain and he does not need more rescue bolus assessed up to 4 hours
Time in minutes of titration of fentanyl and morphine in reducing postoperative pain severe to mild pain with visual analog scale (≤ 3).
4 secondary outcomes
Stay time of patients in the postanesthetic recovery unit in hours.
Time frame: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room assessed up to 4 hours.
Satisfaction with the analgesic management
Time frame: This outcome will be measured in the first hour at the PACU and postoperative 24 hours
Cumulative dosis
Time frame: The outcome will be measured from the patient experiences severe pain at the PACU and is given the first bolus rescue analgesic until is given last bolus rescue analgesic, assessed up to 4 hours
Saturation of oxygen and arterial pressure
Time frame: The outcomes will be measured from the patient arrives at the PACU until he is discharged or transferred to the hospital room, assessed up to 4 hours.
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 23 May 2014.
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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.
Adriana Cadavid, MD principal investigator
Antioquia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl and Morphine in people with Postoperative Pain, run by Universidad de Antioquia at 1 site in Colombia.
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 6 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 23 May 2014. 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 Colombia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time in minutes of titration of fentanyl and morphine in reducing severe postoperative pain to mild pain (time frame: The outcome will be measured from the patient presents severe pain at the PACU until the time that presents mild pain and he does not need more rescue bolus assessed up to 4 hours). 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 23 May 2014.