Hot FlashesPhase 2VMSNCT06161792
Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer
A Phase 2 study testing 0.8 mg RCN3028 in people with Hot Flashes and Breast Cancer, run by Yung Shin Pharm. Ind. Co., Ltd. at 4 sites in Taiwan.
Trial summary
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hot Flashes, Breast Cancer
- What is being tested?
- 0.8 mg RCN3028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 4 sitesTaiwan
- Study dates
- 7 Nov 2019to 20 Apr 2022
- Phase
- Phase 2
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects (aged 20 years or order) with confirmed diagnosis of breast cancer who have completed chemotherapy and radiotherapy, and are on a stable dose of tamoxifen or aromatase inhibitors (AIs) for at least 8 weeks at baseline and will maintain the same treatment regimen and dose throughout the study.
- Reported 7 or more moderate to severe hot flashes per day (average) or 50 moderate to severe hot flashes per week at baseline.
- Screening laboratory values for hematopoietic, hepatic, and renal functions are within the following ranges:
- Hematopoietic : Absolute neutrophil count ≥ 1,500/mm3、Platelet count ≥ 100,000/mm3
- Hepatic : Glutamic Oxaloacetic Transaminase/Glutamic Pyruvic Transaminase ≤ 3 times upper limit of normal (ULN)、Bilirubin ≤ 1.5 times ULN
- Renal : Creatinine ≤ 1.5 times ULN
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- Having Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤ 1.
- Ability to understand and follow the instructions of the investigator, including completion of the study procedures as described in the protocol (i.e., VMS episode event log).
- Able and willing to provide written informed consent.
Who cannot join
- Subjects are pregnant or breastfeeding.
- Female subjects who have childbearing potential, but they are not willing to use effective contraceptive methods during study period and for 1 week afterward.
- Subjects who have multiple primary cancers (except for completely resected basal cell cancer, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer or any other cancer from which the patient has been recurrence-free for at least 5 years).
- Subjects who have inoperable breast cancer (Stage IIIB/IIIC/IV).
- Subjects who have the following medical history: myocardial infarction, congestive heart failure, significant ischemic or valvular heart disease, clinically active interstitial lung disease.
- Subjects who have systolic blood pressure (BP) outside the range 100 to 150 mmHg, diastolic BP outside the range 60 to 90 mmHg, and/or heart rate outside the range 50 to 100 bpm at baseline.
Show all 18Show fewer
- Subjects who had received treatment for hypotension within 30 days prior to screening visit.
- Subjects who have uncontrolled hyperglycemia, HbA1c ≥ 7% at baseline.
- Subjects who have clinical significant conditions such as acute myocardial infarction or stroke with 6 months of randomization.
- Subjects who have a history of Parkinson's disease.
- Subjects are taking risperidone in the 30 days prior to screening visit.
- Subjects who had participated in another clinical trial and received an investigational drug within 30 days prior to screening visit.
- Subjects having a known history of allergic reaction, hypersensitivity or clinically significant intolerance to ingredients of the study drug.
- Subjects with a current drug or alcohol abuse problem as judged by the investigator.
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments or for other reasons are felt to be inappropriate for inclusion in the study as determined by the investigators.
- Subjects who use Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRI), within 4 weeks prior to screening visit.
- Subjects who use herbal or dietary supplements, including black cohosh, soy, phytoestrogens or over the counter agents known to possibly be effective for the treatment of vasomotor symptoms within 2 weeks prior to baseline.
- Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the investigator(s), would compromise the subject's participation in the study.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Changhua Christain Hospital
Changhua
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Taipei Medical University Hospital
Taipei
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of RCN3028 in Treatment of Drug-Induced Moderate to Severe Vasomotor Symptoms in Breast Cancer Subjects
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Read the detailed description
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2a are more likely to cause hypothermia. Risperidone is a potent 5-HT2a and a dopamine D2 receptor antagonist and is proposed to have effect on reduction of hot flashes through its dopaminergic and serotonergic antagonism.
Breast cancer is one of the most common cancers in women, according to the cancer registration report of the Ministry of Health and Welfare (MOHW), in 2014, up to 11,976 women suffered from breast cancer, which meant 33 women suffered from breast cancer daily. Recent epidemiology further disclosed that the incidence of breast cancer was top-ranked (70.74 per 100,000) among cancers of Taiwanese women in 2014.
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
With recent advances of treatment modalities, more than 80% of women with a newly diagnosed breast cancer are expected to survive their disease for 5 years or more. One of the most common complaints was hot flashes induced by the treatment of breast cancer (i.e., tamoxifen induced hot flashes).
In general, hormone replacement therapy (HRT) is the most effective treatment for VMS (hot flashes). However, HRT has been associated with increased risk of recurrence in breast cancer survivors . Moreover, there is some evidence that HRT may not be as effective in women using tamoxifen. Therefore, a new therapy for treating hot flashes in breast cancer patients without increasing the risk of cancer recurrence is needed for such patient population, for example, a non-hormonal therapy. FDA approved low-dose paroxetine capsules (Brisdelle®) as a non-hormonal therapy for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, despite the modest efficacy as compared with placebo, suicidal ideation and the drug-drug interactions (i.e., Brisdelle® and tamoxifen) . Brisdelle® itself is an antidepressant of selective serotonin reuptake inhibitors (SSRI) class. Several trials have recently demonstrated a role for SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the treatment of VMS.
- Conditions
- Hot Flashes, Breast Cancer
- Being tested
- 0.8 mg RCN3028, Placebo
- Keywords
- Hot Flashes
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.8 mg RCN3028Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| I placebo capsule | Placebo comparator | Subjects will be enrolled to about 14-days of placebo-run-in period.
Other Names:
RCN3028 placebo Receives: Drug: Placebo |
| II RCN3028 0.8 mg capsule | Experimental | Subjects will be enrolled to about 14-days of placebo-run-in period. Treatment started at 0.4 mg, titrated to 0.8 mg for maintenance phase.
Other Names:
RCN3028 0.8 mg capsule Receives: Drug: 0.8 mg RCN3028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in frequency of moderate to severe VMS
Mean change in frequency numbers of moderate to severe VMS(Vasomotor Symptoms) from baseline to weeks 4 and week 12. The VMS episode event log recorded the frequency of hot flashes per day, such mild, moderate, severe, nighttime awakening number.
Measured: 4, 12 weeks
Mean change in severity of moderate to severe VMS
Mean change in severity score of moderate to severe VMS from baseline to weeks 4 and week 12. The severity score for VMS for each subject is calculated as the sum of 2 times the number of moderate VMS, plus 3 times the number of severe VMS, divided by the total number of moderate and severe VMS.
Measured: 4, 12 weeks
Secondary outcomes (8)
Menopause Specific Quality of Life Questionnaire
Menopause Specific Quality of Life Questionnaire will be completed at baseline, week 4, week 8 and week 12. Score on a scale Menopause Specific Quality of Life (MENQOL) questionnaire 0=not bothered at all - 6=extremely bothered. 4 domains, mean calculated for set of questions in each domain.
Measured: 12 weeks
The 50%, 75% and 100% responder rates
Subject who had a reduction in the number of moderate and severe hot flashes of at least 50%, at least 75% and 100% from baseline.
Measured: 12 weeks
The time to onset of efficacy
50% reduction in hot flashes for at least 3 consecutive days. The duration of first treatment used to first onset on efficacy will be calculated.
Measured: 12 weeks
Subject's and Physician's Global Assessment
At the end of treatment Visit (week 12) each subject will provide an overall evaluation of study treatment by completing a Subject's Global Assessment. The rating scale for the final assessment by the subject includes: much worse, worse, unchanged, improved, much improved or free of symptoms. At week 12 each investigator will be asked to rate their subject's response to therapy using the same scale.
Measured: 12 weeks
Frequencies(number and percentage) of subjects with treatment-emergent AEs (TEAEs)
Frequencies (number and percentage) of subjects with one or more treatment-emergent AEs (TEAEs) will be summarized by treatment arm, by the Medical Dictionary for Regulatory Activities (MedDRA) system with respect to System Organ Class (SOC) and preferred term.
Measured: 12 weeks
Change from baseline in weekly weighted severity score.
calculated for each week as 2 times the number of moderate hot flashes plus 3 times the number of severe hot flashes plus 3 times the number of nighttime awakenings.
The severity of VMS is defined as follows:
- Mild: sensation of heat without sweating;
- Moderate: sensation of heat with sweating, able to continue activity;
- Severe: sensation of heat with sweating, causing cessation of activity.
- Nighttime awakenings (i.e., episodes that wake the patient from sleep) associated with hot flashes are recorded separately and are considered severe.
Measured: 12 weeks
Change from baseline in the number of mild, moderate, and severe hot flashes.
The weekly frequency will be calculated for each visit.
Measured: 12 weeks
Change from baseline in the number of nighttime awakenings because of hot flashes.
The weekly frequency will be calculated for each visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start7 Nov 2019
- Primary completion14 Mar 2022
- Study completion20 Apr 2022
Why it stopped: Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hui-Ling Shieh, PhD, Study director, Yung Shin Pharm. Ind. Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161792
- Sponsor's protocol ID
- YSP-RCN3028-03
- Acronym
- VMS
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of RCN3028 in Treatment of Drug-Induced Moderate to Severe Vasomotor Symptoms in Breast Cancer Subjects
- ClinicalTrials.gov ID
- NCT06161792
- Acronym / sponsor ID
- VMS / YSP-RCN3028-03
- Conditions
- Hot Flashes, Breast Cancer
- Keywords
- Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 8 Dec 2023 (actual)
- 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.
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Detailed description
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2a are more likely to cause hypothermia. Risperidone is a potent 5-HT2a and a dopamine D2 receptor antagonist and is proposed to have effect on reduction of hot flashes through its dopaminergic and serotonergic antagonism.
Breast cancer is one of the most common cancers in women, according to the cancer registration report of the Ministry of Health and Welfare (MOHW), in 2014, up to 11,976 women suffered from breast cancer, which meant 33 women suffered from breast cancer daily. Recent epidemiology further disclosed that the incidence of breast cancer was top-ranked (70.74 per 100,000) among cancers of Taiwanese women in 2014.
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
With recent advances of treatment modalities, more than 80% of women with a newly diagnosed breast cancer are expected to survive their disease for 5 years or more. One of the most common complaints was hot flashes induced by the treatment of breast cancer (i.e., tamoxifen induced hot flashes).
In general, hormone replacement therapy (HRT) is the most effective treatment for VMS (hot flashes). However, HRT has been associated with increased risk of recurrence in breast cancer survivors . Moreover, there is some evidence that HRT may not be as effective in women using tamoxifen. Therefore, a new therapy for treating hot flashes in breast cancer patients without increasing the risk of cancer recurrence is needed for such patient population, for example, a non-hormonal therapy. FDA approved low-dose paroxetine capsules (Brisdelle®) as a non-hormonal therapy for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, despite the modest efficacy as compared with placebo, suicidal ideation and the drug-drug interactions (i.e., Brisdelle® and tamoxifen) . Brisdelle® itself is an antidepressant of selective serotonin reuptake inhibitors (SSRI) class. Several trials have recently demonstrated a role for SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the treatment of VMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I placebo capsule | Placebo comparator | Drug: PlaceboSubjects will be enrolled to about 14-days of placebo-run-in period. Other Names: RCN3028 placebo |
| II RCN3028 0.8 mg capsule | Experimental | Drug: 0.8 mg RCN3028Subjects will be enrolled to about 14-days of placebo-run-in period. Treatment started at 0.4 mg, titrated to 0.8 mg for maintenance phase. Other Names: RCN3028 0.8 mg capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female subjects (aged 20 years or order) with confirmed diagnosis of breast cancer who have completed chemotherapy and radiotherapy, and are on a stable dose of tamoxifen or aromatase inhibitors (AIs) for at least 8 weeks at baseline and will maintain the same treatment regimen and dose throughout the study.
- Reported 7 or more moderate to severe hot flashes per day (average) or 50 moderate to severe hot flashes per week at baseline.
- Screening laboratory values for hematopoietic, hepatic, and renal functions are within the following ranges:
- Having Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤ 1.
- Ability to understand and follow the instructions of the investigator, including completion of the study procedures as described in the protocol (i.e., VMS episode event log).
Key exclusion criteria (18 listed)
- Subjects are pregnant or breastfeeding.
- Female subjects who have childbearing potential, but they are not willing to use effective contraceptive methods during study period and for 1 week afterward.
- Subjects who have multiple primary cancers (except for completely resected basal cell cancer, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer or any other cancer from which the patient has been recurrence-free for at least 5 years).
- Subjects who have inoperable breast cancer (Stage IIIB/IIIC/IV).
- Subjects who have the following medical history: myocardial infarction, congestive heart failure, significant ischemic or valvular heart disease, clinically active interstitial lung disease.
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 |
|---|---|---|
| 0.8 mg RCN3028Oral | Drug | II RCN3028 0.8 mg capsule |
| PlaceboOral | Drug | I placebo capsule |
Primary outcome
Mean change in frequency of moderate to severe VMS
Time frame: 4, 12 weeks
Mean change in frequency numbers of moderate to severe VMS(Vasomotor Symptoms) from baseline to weeks 4 and week 12. The VMS episode event log recorded the frequency of hot flashes per day, such mild, moderate, severe, nighttime awakening number.
Mean change in severity of moderate to severe VMS
Time frame: 4, 12 weeks
Mean change in severity score of moderate to severe VMS from baseline to weeks 4 and week 12. The severity score for VMS for each subject is calculated as the sum of 2 times the number of moderate VMS, plus 3 times the number of severe VMS, divided by the total number of moderate and severe VMS.
8 secondary outcomes
Menopause Specific Quality of Life Questionnaire
Time frame: 12 weeks
The 50%, 75% and 100% responder rates
Time frame: 12 weeks
The time to onset of efficacy
Time frame: 12 weeks
Subject's and Physician's Global Assessment
Time frame: 12 weeks
Frequencies(number and percentage) of subjects with treatment-emergent AEs (TEAEs)
Time frame: 12 weeks
Change from baseline in weekly weighted severity score.
Time frame: 12 weeks
Change from baseline in the number of mild, moderate, and severe hot flashes.
Time frame: 12 weeks
Change from baseline in the number of nighttime awakenings because of hot flashes.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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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.
hui-Ling Shieh, PhD study director
Yung Shin Pharm. Ind. Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.8 mg RCN3028 in people with Hot Flashes and Breast Cancer, run by Yung Shin Pharm. Ind. Co., Ltd. at 4 sites in Taiwan.
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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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 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?
The study was stopped early (reason given: Difficulty in recruiting breast cancer patients, leading to a slow rate of case enrollment.). Results are not available in the source record.
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?
Mean change in frequency of moderate to severe VMS (time frame: 4, 12 weeks). 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 8 Dec 2023.