Chronic Obstructive Pulmonary DiseasePhase 4NCT03159091
Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Rengalin in people with Chronic Obstructive Pulmonary Disease, run by Materia Medica Holding at 18 sites in Russia.
Trial summary
The purpose of this study is to obtain additional data on efficacy and safety of Rengalin in the treatment of cough in patients with stable obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Rengalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 18 sitesRussia
- Study dates
- 16 Jun 2017to 25 Apr 2019
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged from 40 to 80 years old.
- COPD diagnosed (in accordance with the GOLD-2014 guidelines) ≥12 months before inclusion.
- Stable course of COPD (≥ 6 weeks free of disease progression).
- Mild, moderate or severe degree of bronchial obstruction (FEV1/FVC < 0.7; post-bronchodilator FEV1 ≥30% of predicted value).
- CSS score ≥2.
- Stable dose of standard therapy within the preceding 4 weeks.
- Use of and adherence to contraceptive methods by fertile-age patients of both sexes during the study.
- Availability of a signed patient information sheet (Informed Consent form) for participation in the trial.
Who cannot join
- Earlier diagnosis of intra- or extrathoracic causes of cough (e.g., asthma, malignant neoplasm of lung, tuberculosis, sarcoidosis, α1-antitrypsin deficiency, bronchiectasis, cystic fibrosis, interstitial pulmonary diseases, perennial allergic rhinitis, gastro-oesophageal reflux disease, use of ACE inhibitors, disease of upper respiratory tract, etc.).
- Cough associated with eating.
- An exacerbation of COPD, acute upper and/or lower respiratory infection at inclusion or in the previous 4 weeks.
- Modifications to standard drug therapy (dose escalation, replacement of medicines prescribed or addition of new medications) in the previous 4 weeks.
- Very severe degree of bronchial obstruction (post-bronchodilator FEV1 <30% pred or < 50% and chronic respiratory failure).
- Haemoptysis.
Show all 25Show fewer
- Stroke in the preceding 3 months or stroke with long-term residual neurological deficit within 6 months before study entry.
- Acute coronary syndrome, myocardial infarction within 6 months before study enrollment.
- Unstable or life-threatening arrhythmia in the previous 3 months.
- Acute or chronic heart failure (NYHA (1964) Class III or IV).
- Presence or suspicion of oncological disease.
- Body Mass Index (BMI) ≤18 kg/m2 or ≥40 kg/m2.
- Chronic kidney disease (categories С3-5 А3).
- Hepatic failure (Child-Pugh class C)
- Exacerbation or decompensation of a chronic disease that would affect the patient's ability to participate in the clinical trial.
- For smokers - intention to quit smoking in the next 4 weeks.
- Allergy/intolerance to any of the components of medications used in the treatment.
- Course intake of medicines listed in the section 'Prohibited concomitant treatment' for 4 weeks prior to the enrollment in the trial.
- Participation in other clinical trials within 3 months prior to the enrollment in this study.
- Patients who, from investigator's point of view, will fail to comply with the observation requirements of the trial or with the dosing regimen of the investigational drug.
- Other conditions preventing the patient from normal participation (e.g., planned business or other trips).
- Drug addiction, alcohol use in the amount over 2 units of alcohol a day, mental diseases.
- Pregnancy, breast-feeding, unwillingness to use contraception during the study.
- Patient is related to the research staff of the clinical investigative site who are directly involved in the trial or is the immediate family member of the investigator. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
- Patient works for MATERIA MEDICA HOLDING company (i.e., is the company's employee, temporary contract worker or appointed official responsible for carrying out the research or their immediate family).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Regional state budgetary health care institution "Regional Clinical Hospital"
Barnaul, 656024
Regional state budget health care institution "City Hospital No. 5, Barnaul"
Barnaul, 656045
NUZ "Road Clinical Hospital at the station Chelyabinsk JSC" RZhD "
Chelyabinsk, 454000
The State Budget Health Institution "Regional Clinical Hospital No. 4"
Chelyabinsk, 454021
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Central City Clinical Hospital and Clinic #18
Kazan', 420012
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University"/Professor's Clinic
Kazan', 420012
Pirogov Russian National Research Medical University
Moscow, 117997
State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City Clinical Hospital No. 10"
Nizhny Novgorod, 603011
Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, 390026
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, 191015
North-western State Medical University named after I.I.Mechnikov
Saint Petersburg, 191015
St. Petersburg State Budgetary Public Health Institution "Vvedensky City Clinical Hospital"
Saint Petersburg, 191180
The Federal State Institute of Public Health 'The Nikiforov Russian Center of Emergency and Radiation Medicine'
Saint Petersburg, 194044
The First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197022
St. Petersburg State Budgetary Institution of Health "City Polyclinic No. 106"
Saint Petersburg, 198328
Samara City Hospital №4
Samara, 443056
St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"
Sestroretsk, 197706
Voronezh Regional Clinical Hospital №1
Voronezh, 394066
About this study
Official title: Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to obtain additional data on efficacy and safety of Rengalin in the treatment of cough in patients with stable obstructive pulmonary disease
Read the detailed description
Design: multicenter, double-blind, randomized, parallel group placebo-controlled study.
The study will enroll men and women (aged 40 to 80 years) with cough associated with stable chronic obstructive pulmonary disease (COPD). Subjects with COPD diagnosed more than 12 months earlier obtaining allowed basic therapy and retaining cough ≥2 points (according to cough severity scale [CSS]) despite their therapy should be considered as the study candidates.
After signing patient information leaflet (informed consent form) to participate in the clinical study, collection of medical history and objective examination are performed, cough severity is assessed (using CSS; at baseline evaluation of diurnal and nocturnal cough the number of episodes and cough severity in the preceding day is taken into account) as well as intensity of COPD effect on the subject (САТ test), concomitant therapy is recorded, computer spirometry with evaluation of baseline FEV1/FVC and post-bronchodilator FEV1 (where respiratory function cannot be assessed, the results of the previous examination dating no more than 3 months earlier may be used). Females of childbearing potential will undergo pregnancy test.
If a patient meets the inclusion criteria and does not demonstrate any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of 2 groups: group 1 patients will receive Rengalin at 2 tablets 3 times a day for 4 weeks; group 2 patients will receive placebo using Rengalin dosing regimen for 4 weeks.
The patient will be monitored for 4 weeks (screening, randomization - before day 1, treatment - 4 weeks). During follow-up period two visits are scheduled (Visit 1 (Day 1) and Visit 2 (Week 4) at which objective examination, recording cough severity (using CSS) will be carried out, COPD effect on the subjects (САТ test) and concomitant therapy will be evaluated. At Visit 2 (after 4-week treatment period) compliance will be additionally assessed.
At one of the clinical sites (Research Institute of Pulmonology, Russian FMBA), patients will be monitored for cough on a daily basis (using the WHolter™ monitor), with the data used as an additional measure to evaluate efficacy.
Subjects are allowed to take basic COPD therapy and medications for their co-morbidities in the course of the study, except for the medicines listed in "Prohibited concomitant treatment".
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Rengalin, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RengalinDrug
Oral administration.
PlaceboDrug
Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Rengalin | Experimental | Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal). Receives: Drug: Rengalin |
| Placebo | Placebo comparator | Oral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With a Positive Treatment Response
Cough Severity Scale (CSS) total score. Cough intensity according to the scale is assessed in daytime and at night in points where 0 - no cough, 5 - continuous exhausting cough in daytime and at night. Response criterion: ≥1 lower total CSS score compared to baseline.
Measured: in 4 weeks of the treatment
Secondary outcomes (4)
Severity of Cough After 4 Weeks Compared to Baseline
Cough Severity Scale (CSS) total score. Cough intensity according to the scale is assessed in the daytime and at night in points, where 0 - no cough, 5 - continuous exhausting cough in the daytime, and at night.
Measured: Baseline and 4 weeks after the treatment
Percentage of Patients With ≥50% Lesser Cough Severity at 4 Weeks
Number of Participants with a Decrease from Baseline of ≥50% in Cough Severity at 4 weeks. Based on the total Cough Severity Scale (CSS) score. Cough intensity according to the scale is assessed in the daytime and at night in points, where 0 - no cough, 5 - continuous exhausting cough in the daytime and at night.
Measured: in 4 weeks of the treatment
Changes in Clinical Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
Based on the total COPD Assessment Test (CAT) score. CAT consists of 8 items. Each item ranges from "0" to "5" balls. The total score ranges from minimum "0" to maximum "40" points. Higher values represent a worse outcome.
Measured: in 4 weeks of the treatment
Percentage of Patients With no Exacerbation of COPD
COPD exacerbation is defined as an acute event characterized by aggravation of the event within 2-3 or more days. Exacerbation manifests in intensification of respiratory disorders beyond their regular daily fluctuations and require administration of products in addition to the previously prescribed basic therapy as well as a rescue drug for symptom relief (salbutamol). Additional products include antibacterial drugs, systemic corticosteroids and/or emergency therapy (ambulance call) or hospitalization for COPD exacerbation.
COPD exacerbation is recorded as an adverse event. If a COPD exacerbation develops within the first week of the subject participation in the study, it will not be considered as a secondary inefficacy criterion
Measured: in 4 weeks of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start16 Jun 2017
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159091
- Sponsor's protocol ID
- MMH-RN-005
- Status last verified
- Aug 2019
- First submitted
- 17 May 2017
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avdeev SN, Vizel AA, Abrosimov VN, Zaicev AA, Ignatova GL, Khamitov RF, Mikhaylusova MP, Shapovalova JS, Pavlysh EF, Trofimov BI, Emelyanov AV, Martynenko TI, Martynenko VA, Kostina NE, Chizhov DA, Chizhova OY, Kuzubova NA, Makova EV, Makarova EV. Management of Cough in Patients with Chronic Obstructive Pulmonary Disease: Results of the Multicenter Randomized Placebo-Controlled Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2021 May 5;16:1243-1253. doi: 10.2147/COPD.S292109. eCollection 2021.
PubMed 33981141
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Rengalin in the Treatment of Cough in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03159091
- Acronym / sponsor ID
- MMH-RN-005
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 11 Dec 2020
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 study is to obtain additional data on efficacy and safety of Rengalin in the treatment of cough in patients with stable obstructive pulmonary disease
Detailed description
Design: multicenter, double-blind, randomized, parallel group placebo-controlled study.
The study will enroll men and women (aged 40 to 80 years) with cough associated with stable chronic obstructive pulmonary disease (COPD). Subjects with COPD diagnosed more than 12 months earlier obtaining allowed basic therapy and retaining cough ≥2 points (according to cough severity scale [CSS]) despite their therapy should be considered as the study candidates.
After signing patient information leaflet (informed consent form) to participate in the clinical study, collection of medical history and objective examination are performed, cough severity is assessed (using CSS; at baseline evaluation of diurnal and nocturnal cough the number of episodes and cough severity in the preceding day is taken into account) as well as intensity of COPD effect on the subject (САТ test), concomitant therapy is recorded, computer spirometry with evaluation of baseline FEV1/FVC and post-bronchodilator FEV1 (where respiratory function cannot be assessed, the results of the previous examination dating no more than 3 months earlier may be used). Females of childbearing potential will undergo pregnancy test.
If a patient meets the inclusion criteria and does not demonstrate any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of 2 groups: group 1 patients will receive Rengalin at 2 tablets 3 times a day for 4 weeks; group 2 patients will receive placebo using Rengalin dosing regimen for 4 weeks.
The patient will be monitored for 4 weeks (screening, randomization - before day 1, treatment - 4 weeks). During follow-up period two visits are scheduled (Visit 1 (Day 1) and Visit 2 (Week 4) at which objective examination, recording cough severity (using CSS) will be carried out, COPD effect on the subjects (САТ test) and concomitant therapy will be evaluated. At Visit 2 (after 4-week treatment period) compliance will be additionally assessed.
At one of the clinical sites (Research Institute of Pulmonology, Russian FMBA), patients will be monitored for cough on a daily basis (using the WHolter™ monitor), with the data used as an additional measure to evaluate efficacy.
Subjects are allowed to take basic COPD therapy and medications for their co-morbidities in the course of the study, except for the medicines listed in "Prohibited concomitant treatment".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rengalin | Experimental | Drug: RengalinOral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal). |
| Placebo | Placebo comparator | Drug: PlaceboOral administration. Two tablets per intake. The tablet should be held in the mouth until complete dissolution. 2 tablets 3 times a day without food (i.e. 15-30 min prior to meal or 15-30 min after meal). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of both sexes aged from 40 to 80 years old.
- COPD diagnosed (in accordance with the GOLD-2014 guidelines) ≥12 months before inclusion.
- Stable course of COPD (≥ 6 weeks free of disease progression).
- Mild, moderate or severe degree of bronchial obstruction (FEV1/FVC < 0.7; post-bronchodilator FEV1 ≥30% of predicted value).
- CSS score ≥2.
Key exclusion criteria (25 listed)
- Earlier diagnosis of intra- or extrathoracic causes of cough (e.g., asthma, malignant neoplasm of lung, tuberculosis, sarcoidosis, α1-antitrypsin deficiency, bronchiectasis, cystic fibrosis, interstitial pulmonary diseases, perennial allergic rhinitis, gastro-oesophageal reflux disease, use of ACE inhibitors, disease of upper respiratory tract, etc.).
- Cough associated with eating.
- An exacerbation of COPD, acute upper and/or lower respiratory infection at inclusion or in the previous 4 weeks.
- Modifications to standard drug therapy (dose escalation, replacement of medicines prescribed or addition of new medications) in the previous 4 weeks.
- Very severe degree of bronchial obstruction (post-bronchodilator FEV1 <30% pred or < 50% and chronic respiratory failure).
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 |
|---|---|---|
| RengalinOral administration. | Drug | Rengalin |
| PlaceboOral administration. | Drug | Placebo |
Primary outcome
Percentage of Patients With a Positive Treatment Response
Time frame: in 4 weeks of the treatment
Cough Severity Scale (CSS) total score. Cough intensity according to the scale is assessed in daytime and at night in points where 0 - no cough, 5 - continuous exhausting cough in daytime and at night. Response criterion: ≥1 lower total CSS score compared to baseline.
4 secondary outcomes
Severity of Cough After 4 Weeks Compared to Baseline
Time frame: Baseline and 4 weeks after the treatment
Percentage of Patients With ≥50% Lesser Cough Severity at 4 Weeks
Time frame: in 4 weeks of the treatment
Changes in Clinical Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
Time frame: in 4 weeks of the treatment
Percentage of Patients With no Exacerbation of COPD
Time frame: in 4 weeks of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33981141Avdeev SN, Vizel AA, Abrosimov VN, Zaicev AA, Ignatova GL, Khamitov RF, Mikhaylusova MP, Shapovalova JS, Pavlysh EF, Trofimov BI, Emelyanov AV, Martynenko TI, Martynenko VA, Kostina NE, Chizhov DA, Chizhova OY, Kuzubova NA, Makova EV, Makarova EV. Management of Cough in Patients with Chronic Obstructive Pulmonary Disease: Results of the Multicenter Randomized Placebo-Controlled Clinical Trial. Int J Chron Obstruct Pulmon Dis. 2021 May 5;16:1243-1253. doi: 10.2147/COPD.S292109. eCollection 2021.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rengalin in people with Chronic Obstructive Pulmonary Disease, run by Materia Medica Holding at 18 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. 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. 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 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?
Yes. Results are posted in the registry (first posted 11 Dec 2020). 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?
Percentage of Patients With a Positive Treatment Response (time frame: in 4 weeks of the treatment). 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 NCT03159091, which also lists 1 linked publication.
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 11 Dec 2020.