Acute PainPhase 4PENTRANCT01887951
Penthrox Versus Tramadol for SCDF
A Phase 4 study testing Penthrox Inhaler and Tramadol Injection in people with Acute Pain, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Introduction Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Penthrox Inhaler and Tramadol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2014to Oct 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute pain, with pain score greater than 3, presenting with musculo-skeletal trauma (limbs or back) pain are eligible
- Conscious, haemodynamically stable condition (BP greater than 90/60)
- Age more than 16 years old
Who cannot join
- General
- Females who are nursing or with a positive pregnancy test (pregnant)
- Patients with major head injury or impaired consciousness
- Acute intoxication with drugs or alcohol, or other conditions that might impair ability to score pain
- Chronic pain requiring ongoing use of analgesics
- Abdominal or chest pain (for the purpose of this initial implementation study)
Show all 14Show fewer
- Penthrox only
- Known pre-existing renal or hepatic impairment
- Hypersensitivity to fluorinated anaesthetics or a history of possible adverse reactions in either the patients or relatives (malignant hyperthermia)
- Concomitant use of nephrotoxic medications such as gentamicin or tetracycline
- Tramadol only
- Any allergies to tramadol or codeine
- Any history of seizures, epilepsy
- Patients who are taking anti-depressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Penthrox (Methoxyflurane)and Tramadol for the Singapore Emergency Ambulance Service
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug.
Read more
Aim
To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS.
Methodology
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per station level. After 6 months, they will cross over to Penthrox and tramadol respectively.
All paramedics will be trained to use both medications, pain scales and Ramsey scores, and will record patient's pain, sedation scores and patient satisfaction as part of routine clinical practice. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
Hypothesis
The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.
Read the detailed description
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. In addition, there are problems with storage, leakage, maintenance and occupational exposure of the EAS crew members. Therefore, there is a need for better standard of care treatment.
Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug. We intend to conduct a clinical evaluation trial comparing the use of inhaled Penthrox with IM Tramadol for early pain relief.
Objective \& Hypothesis
Primary objectives:
To compare Penthrox (methoxyflurane) and Tramadol in the treatment of acute pain in patients transported by the Singapore Civil Defense Force (SCDF) EAS with respect to:
- Pain Score assessed by Visual Analogue Scale (VAS) at 5,10, 15 and 20 min after start of the study treatment
- Time arrived at scene to delivery of first analgesia
- Time to onset of analgesia (arrive at scene to ≥ 3 point reduction in pain score assessed by VAS)
Secondary Objective:
- To understand patients' perception of pain, satisfaction in pain management, and the use of the analgesic inhaler compared with IM tramadol in the treatment of acute pain.
- To understand staff satisfaction with pain management, and the ease of use of the analgesic inhaler compared with IM tramadol in the treatment of acute pain.
- To assess Ramsay sedation scores at 5, 10, 15 and 20 min after start of the study treatment
- Vital signs (i.e. Respiratory rate, heart rate, blood pressure and GCS)
Methods Study Design
A phased, prospective, non-randomised, before-after evaluation study comparing Penthrox (Methoxyflurane) and Tramadol in patients with acute pain managed by SCDF EAS.
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). 200 samples of Penthrox will be provided free of charge by Medical Developments International (MDI), an Australian company, for evaluation during the trial. Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Intramuscular tramadol will be purchased by SCDF for this implementation trial.
Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with IM tramadol. Allocation will be on a per station level. After 6 months, the two separate cohort of ambulances will cross over to administer Penthrox and Tramadol and respectively. This is done in order to minimize any potential patient selection bias and ambulance crew operator bias arising in the two 6-monthly time periods.
All paramedics will be trained to use both medications, the pain scales and Ramsey scores, and will record patient's pain, sedation scores patient and staff satisfaction as part of routine clinical practice. In the case when one or both study drugs are used up before the cross-over period, or the patient is ineligible for either drug, SCDF ambulances will still carry Enthanox as a back up analgesia.
SGH will be submitting an ethics application to Centralised Institutional Review Board (CIRB) on behalf of SCDF to recruit all cases presenting to SCDF, irrespective of destination hospital. This is because SCDF does not have its own IRB. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
Enrollment of Patients Patients will be given the treatment if all eligibility criteria are met and treatment is indicated by protocol. For patients who do not meet inclusion and exclusion criteria for either of the new treatments, Enthanox will still be kept on ambulances during the study period for back up analgesia. No written consent will be sought as this will be part of routine clinical care.
Team members Contribution SCDF staff members will be enrolling eligible participants and administer the study drugs. The SGH study team will provide clinical input into protocols, physician oversight, training for paramedics, data quality control, analysis of data and interpretation of results etc.
Quality Assurance
This study will include the following specific elements for quality assurance:
- Development of standard protocols to perform all data collection and follow-up activities
- Development and adherence to a detailed Standard Operation Procedures (SOP)
- Use of standardized forms and uniform criteria for patient recruitment
- Standardized data processing, editing and generation of edit statements
- Regular communications between the study investigators to resolve questions
- Internal and external monitoring of data collection
Additional steps to ensure data quality include: range checks and verification built into the data entry system and a sequence of logic checking and examination of variables.
Human Subjects Instructions
Risk Reduction
- A formal education and training program will be conducted for all paramedics who will be administering both treatments to patients. This will include didactic and practical training sessions, and competency certification before they will be allow to administer the treatment. Paramedics will also be taught how to monitor patients, watch for adverse effects and how to treat them.
A formal education and training program will be conducted for all investigators who will be conducting surveys to reduce the risks regarding confidentiality. All subjects' identifiers will be removed from the database to protect subjects' confidentiality.
Risk/Benefit
- Comparison of Penthrox and Tramadol will help to advise which drug can be used as a standard drug in the EAS for treatment of acute pain patients. This study has the potential to change practice in Singapore and beyond, and allow patients earlier relief of pain and suffering.
Compensation Plan - No compensation will be provided to the patients or any family members.
Informed Consent Issues
- Apply for waiver of consent for this study. Only collecting patients' pain scale information from SCDF EAS. Therefore, it poses no additional risks to the patients. All patient identifiers will be subsequently removed from the dataset.
- Conditions
- Acute Pain
- Being tested
- Penthrox Inhaler, Tramadol Injection
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penthrox InhalerDrug
Tramadol InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time Receives: Drug: Tramadol Injection |
| Penthrox | Experimental | Dosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml. Receives: Drug: Penthrox Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score assessed by Visual Analogue Scale (VAS)
Measured: 5, 10, 15 and 20 min
Secondary outcomes (1)
Change in Ramsay sedation Scores
Measured: 5, 10, 15 and 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887951
- Sponsor's protocol ID
- CIRB 2013/044/C
- Acronym
- PENTRA
- Status last verified
- Feb 2017
- First submitted
- 20 Jun 2013
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Penthrox (Methoxyflurane)and Tramadol for the Singapore Emergency Ambulance Service
- ClinicalTrials.gov ID
- NCT01887951
- Acronym / sponsor ID
- PENTRA / CIRB 2013/044/C
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Jun 2013 (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.
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug.
Aim
To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS.
Methodology
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per station level. After 6 months, they will cross over to Penthrox and tramadol respectively.
All paramedics will be trained to use both medications, pain scales and Ramsey scores, and will record patient's pain, sedation scores and patient satisfaction as part of routine clinical practice. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
Hypothesis
The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.
Detailed description
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. In addition, there are problems with storage, leakage, maintenance and occupational exposure of the EAS crew members. Therefore, there is a need for better standard of care treatment.
Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug. We intend to conduct a clinical evaluation trial comparing the use of inhaled Penthrox with IM Tramadol for early pain relief.
Objective \& Hypothesis
Primary objectives:
To compare Penthrox (methoxyflurane) and Tramadol in the treatment of acute pain in patients transported by the Singapore Civil Defense Force (SCDF) EAS with respect to:
- Pain Score assessed by Visual Analogue Scale (VAS) at 5,10, 15 and 20 min after start of the study treatment
- Time arrived at scene to delivery of first analgesia
- Time to onset of analgesia (arrive at scene to ≥ 3 point reduction in pain score assessed by VAS)
Secondary Objective:
- To understand patients' perception of pain, satisfaction in pain management, and the use of the analgesic inhaler compared with IM tramadol in the treatment of acute pain.
- To understand staff satisfaction with pain management, and the ease of use of the analgesic inhaler compared with IM tramadol in the treatment of acute pain.
- To assess Ramsay sedation scores at 5, 10, 15 and 20 min after start of the study treatment
- Vital signs (i.e. Respiratory rate, heart rate, blood pressure and GCS)
Methods Study Design
A phased, prospective, non-randomised, before-after evaluation study comparing Penthrox (Methoxyflurane) and Tramadol in patients with acute pain managed by SCDF EAS.
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). 200 samples of Penthrox will be provided free of charge by Medical Developments International (MDI), an Australian company, for evaluation during the trial. Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Intramuscular tramadol will be purchased by SCDF for this implementation trial.
Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with IM tramadol. Allocation will be on a per station level. After 6 months, the two separate cohort of ambulances will cross over to administer Penthrox and Tramadol and respectively. This is done in order to minimize any potential patient selection bias and ambulance crew operator bias arising in the two 6-monthly time periods.
All paramedics will be trained to use both medications, the pain scales and Ramsey scores, and will record patient's pain, sedation scores patient and staff satisfaction as part of routine clinical practice. In the case when one or both study drugs are used up before the cross-over period, or the patient is ineligible for either drug, SCDF ambulances will still carry Enthanox as a back up analgesia.
SGH will be submitting an ethics application to Centralised Institutional Review Board (CIRB) on behalf of SCDF to recruit all cases presenting to SCDF, irrespective of destination hospital. This is because SCDF does not have its own IRB. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
Enrollment of Patients Patients will be given the treatment if all eligibility criteria are met and treatment is indicated by protocol. For patients who do not meet inclusion and exclusion criteria for either of the new treatments, Enthanox will still be kept on ambulances during the study period for back up analgesia. No written consent will be sought as this will be part of routine clinical care.
Team members Contribution SCDF staff members will be enrolling eligible participants and administer the study drugs. The SGH study team will provide clinical input into protocols, physician oversight, training for paramedics, data quality control, analysis of data and interpretation of results etc.
Quality Assurance
This study will include the following specific elements for quality assurance:
- Development of standard protocols to perform all data collection and follow-up activities
- Development and adherence to a detailed Standard Operation Procedures (SOP)
- Use of standardized forms and uniform criteria for patient recruitment
- Standardized data processing, editing and generation of edit statements
- Regular communications between the study investigators to resolve questions
- Internal and external monitoring of data collection
Additional steps to ensure data quality include: range checks and verification built into the data entry system and a sequence of logic checking and examination of variables.
Human Subjects Instructions
Risk Reduction
- A formal education and training program will be conducted for all paramedics who will be administering both treatments to patients. This will include didactic and practical training sessions, and competency certification before they will be allow to administer the treatment. Paramedics will also be taught how to monitor patients, watch for adverse effects and how to treat them.
A formal education and training program will be conducted for all investigators who will be conducting surveys to reduce the risks regarding confidentiality. All subjects' identifiers will be removed from the database to protect subjects' confidentiality.
Risk/Benefit
- Comparison of Penthrox and Tramadol will help to advise which drug can be used as a standard drug in the EAS for treatment of acute pain patients. This study has the potential to change practice in Singapore and beyond, and allow patients earlier relief of pain and suffering.
Compensation Plan - No compensation will be provided to the patients or any family members.
Informed Consent Issues
- Apply for waiver of consent for this study. Only collecting patients' pain scale information from SCDF EAS. Therefore, it poses no additional risks to the patients. All patient identifiers will be subsequently removed from the dataset.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: Tramadol InjectionTramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time |
| Penthrox | Experimental | Drug: Penthrox InhalerDosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute pain, with pain score greater than 3, presenting with musculo-skeletal trauma (limbs or back) pain are eligible
- Conscious, haemodynamically stable condition (BP greater than 90/60)
- Age more than 16 years old
Key exclusion criteria (14 listed)
- General
- Females who are nursing or with a positive pregnancy test (pregnant)
- Patients with major head injury or impaired consciousness
- Acute intoxication with drugs or alcohol, or other conditions that might impair ability to score pain
- Chronic pain requiring ongoing use of analgesics
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 |
|---|---|---|
| Penthrox Inhaler | Drug | Penthrox |
| Tramadol Injection | Drug | Tramadol |
Primary outcome
Change in Pain Score assessed by Visual Analogue Scale (VAS)
Time frame: 5, 10, 15 and 20 min
1 secondary outcome
Change in Ramsay sedation Scores
Time frame: 5, 10, 15 and 20 min
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 10 Feb 2017.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Penthrox Inhaler and Tramadol Injection in people with Acute Pain, run by Singapore General Hospital at 1 site in Singapore.
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 14 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 10 Feb 2017. 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 Singapore. 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?
Change in Pain Score assessed by Visual Analogue Scale (VAS) (time frame: 5, 10, 15 and 20 min). 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 10 Feb 2017.