AsthmaPhase 2NCT02720081
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
A Phase 2 study testing MK-1029 150 mg, Montelukast 10 mg and Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK-1029 150 mg, Montelukast 10 mg and Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2016to 6 Sep 2017
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of persistent asthma for at least one year
- History of asthma treatments including "as-needed" inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s)
- Must be able to discontinue or taper asthma controlling medications while receiving Montelukast
- No history of smoking or no smoking for at least 1 year, with a smoking history of no more than 10 pack-years
- Body Mass Index (BMI) of 15 kg/m^2 to 40 kg/m^2.
- Females must not be pregnant (negative serum human chorionic gonadotropin test) or breastfeeding and must not plan to become pregnant for the duration of the study, including the post-treatment follow-up period
- Women and male participants of reproductive potential must agree to use adequate contraception for the duration of the study
Who cannot join
- Evidence of another active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD)
- Unable to perform acceptable, repeatable spirometry
- History of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months of screening visit
- Major surgical procedure(s) within 4 weeks of screening visit
- Blood donation within 2 weeks of screening visit
- Treatment in an emergency room for asthma (within 4 weeks) or hospitalization for asthma or respiratory condition within 2 months of screening visit
Show all 16Show fewer
- Evidence of active sinus disease within 2 weeks of screening visit
- Upper respiratory infection (viral or bacterial) within 1 month of screening visit
- History of a psychiatric disorder within 3 months of screening visit
- History of human immunodeficiency virus (HIV)
- Unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems
- History of cancer (except for successfully treated basal and squamous cell carcinomas of the skin) within 5 years of screening visit
- Uncontrolled hypertension
- Participation in a clinical trial involving an investigational drug within 4 weeks of screening visit
- Hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors or any of their ingredients, including lactose and galactose
- Known sensitivity to or has not had previous exposure to aspirin or non-steroidal anti-inflammatory drugs
About this study
Official title: A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects With Persistent Asthma That is Uncontrolled While Receiving Montelukast.
The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.
- Conditions
- Asthma
- Being tested
- MK-1029 150 mg, MK-1029 Matching-image Placebo, Montelukast 10 mg, Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1029 150 mgDrug
150 mg tablet administered orally, once a day (QD), at bedtime
MK-1029 Matching-image PlaceboDrug
Matching-image placebo tablet administered orally, QD, at bedtime
Montelukast 10 mgDrug
Also called SINGULAIR®, Montelukast sodium
10 mg tablet administered orally, QD, at bedtime
Albuterol/Salbutamol 90 mcg - 100 mcg per inhalationDrug
1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication
| Study group | Role | What they receive |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Experimental | Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. Receives: Drug: MK-1029 150 mg; Drug: Montelukast 10 mg; Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation |
| MK-1029 Placebo + Montelukast 10 mg | Placebo comparator | Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. Receives: Drug: MK-1029 Matching-image Placebo; Drug: Montelukast 10 mg; Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.
Measured: Before the first dose of study investigational product (Baseline)
Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6.
Measured: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
Secondary outcomes (24)
Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6
A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake "all night"; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing.
Measured: Up to 4 weeks
Percentage of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 8 weeks
Percentage of Participants Who Discontinued Study Drug Due to an AE
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 6 weeks
Change From Baseline in Alkaline Phosphatase (ALP) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Alanine Aminotransferase (ALT) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Aspartate Aminotransferase (AST) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Bilirubin at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Eosinophil (Percent [%]) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Neutrophil (%) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Platelet Count at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in White Blood Cell Count at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Hematocrit (%) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Systolic Blood Pressure at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 4
Change From Baseline in Systolic Blood Pressure at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Diastolic Blood Pressure at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 4
Change From Baseline in Diastolic Blood Pressure at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Heart Rate at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 2
Change From Baseline in Heart Rate at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 4
Change From Baseline in Heart Rate at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Change From Baseline in Respiratory Rate at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 2
Change From Baseline in Respiratory Rate at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 4
Change From Baseline in Respiratory Rate at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start11 May 2016
- Primary completion16 Aug 2017
- Study completion6 Sep 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.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720081
- Sponsor's protocol ID
- 1029-015
- Other IDs
- 2015-005054-36, MK-1029-015, 163313, 2015
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2016
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects With Persistent Asthma That is Uncontrolled While Receiving Montelukast.
- ClinicalTrials.gov ID
- NCT02720081
- Acronym / sponsor ID
- 1029-015
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Experimental | Drug: MK-1029 150 mg, Drug: Montelukast 10 mg, Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalationParticipants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. |
| MK-1029 Placebo + Montelukast 10 mg | Placebo comparator | Drug: MK-1029 Matching-image Placebo, Drug: Montelukast 10 mg, Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalationParticipants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptoms of persistent asthma for at least one year
- History of asthma treatments including "as-needed" inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s)
- Must be able to discontinue or taper asthma controlling medications while receiving Montelukast
- No history of smoking or no smoking for at least 1 year, with a smoking history of no more than 10 pack-years
- Body Mass Index (BMI) of 15 kg/m^2 to 40 kg/m^2.
Key exclusion criteria (16 listed)
- Evidence of another active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD)
- Unable to perform acceptable, repeatable spirometry
- History of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months of screening visit
- Major surgical procedure(s) within 4 weeks of screening visit
- Blood donation within 2 weeks of screening visit
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 |
|---|---|---|
| MK-1029 150 mg150 mg tablet administered orally, once a day (QD), at bedtime | Drug | MK-1029 150 mg + Montelukast 10 mg |
| MK-1029 Matching-image PlaceboMatching-image placebo tablet administered orally, QD, at bedtime | Drug | MK-1029 Placebo + Montelukast 10 mg |
| Montelukast 10 mgAlso: SINGULAIR®, Montelukast sodium10 mg tablet administered orally, QD, at bedtime | Drug | MK-1029 150 mg + Montelukast 10 mg, MK-1029 Placebo + Montelukast 10 mg |
| Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication | Drug | MK-1029 150 mg + Montelukast 10 mg, MK-1029 Placebo + Montelukast 10 mg |
Primary outcome
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)
Time frame: Before the first dose of study investigational product (Baseline)
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.
Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6
Time frame: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6.
24 secondary outcomes
Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6
Time frame: Up to 4 weeks
Percentage of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 8 weeks
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 6 weeks
Change From Baseline in Alkaline Phosphatase (ALP) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Alanine Aminotransferase (ALT) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Aspartate Aminotransferase (AST) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Bilirubin at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Eosinophil (Percent [%]) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Neutrophil (%) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Platelet Count at Week 6
Time frame: Baseline and Week 6
Change From Baseline in White Blood Cell Count at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Hematocrit (%) at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Systolic Blood Pressure at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Systolic Blood Pressure at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Diastolic Blood Pressure at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Diastolic Blood Pressure at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Heart Rate at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Heart Rate at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Heart Rate at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Respiratory Rate at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Respiratory Rate at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Respiratory Rate at Week 6
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-1029 150 mg, Montelukast 10 mg and Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation in people with Asthma, run by Merck Sharp & Dohme LLC.
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 7 inclusion and 16 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 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?
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) (time frame: Before the first dose of study investigational product (Baseline)). 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?
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 27 Sep 2018.