AUDPhase 2NCT07333638
Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disorder
A Phase 2 study testing low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) and high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling) in people with AUD, run by Shenzhen Sciencare Medical Industries Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The study plans to enroll 210 adult patients with alcohol use disorder. After signing the informed consent form and undergoing screening based on inclusion/exclusion criteria, eligible participants will be randomly assigned to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AUD
- What is being tested?
- low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) and high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2023to 10 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the informed consent form; willing and able to comply with and complete all trial procedures; |
- Age ≥18 years at the time of signing the informed consent form; |
- Diagnosis of moderate or severe Alcohol Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (meeting four or more diagnostic criteria, see Appendix 1 for details); |
- Completed detoxification treatment and had no significant alcohol withdrawal symptoms for at least one week (≥7 days) prior to randomization/administration [Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score <7 points (see Appendix 2 for specific assessment method)]; |
- Able to provide Timeline Followback (TLFB) alcohol use information for the 2 weeks during detoxification and/or prior to screening; |
- Had at least two heavy drinking days per week during the 4 weeks of detoxification and/or prior to screening; |
- Qualified subjects of childbearing potential (male and female) must agree to use effective contraceptive methods (hormonal or barrier method or abstinence) with their partner during the trial period.
Who cannot join
- The investigator judges that participation in this study is not in the best interest of the subject, or any other condition that would make it unsafe for the subject to participate in the study; |
- Pregnancy, positive pregnancy test for women of childbearing potential, or lactating women, including women of childbearing potential planning to become pregnant during the study period. Note: Women of childbearing potential here refer to women capable of becoming pregnant. Must meet the following criteria, regardless of sexual orientation or tubal ligation: 1) No hysterectomy or bilateral oophorectomy; or 2) Have not been naturally postmenopausal for more than 12 consecutive months (i.e., have had menses at any time in the preceding 12 consecutive months); |
- Significant abnormal liver function (e.g., AST or ALT >2 times the upper limit of normal) or liver failure [including but not limited to: ascites, prolonged prothrombin time, International Normalized Ratio (INR) ≥1.7, esophageal variceal disease] or hepatobiliary ultrasound shows results that significantly impact the judgment of the study drug's efficacy and safety; |
- Suffering from clinically uncontrolled active infectious diseases, such as active Hepatitis B [Hepatitis B surface antigen (HBsAg) positive and Hepatitis B virus (HBV) DNA copy number >1000 IU/ml], active Hepatitis C [Hepatitis C virus antibody positive and Hepatitis C virus (HCV)-RNA positive], etc.; |
- History of congenital bleeding disorders (e.g., hemophilia) or any clinically significant active bleeding, or platelet dysfunction, or prothrombin time (PT) exceeding the upper normal limit by more than 3 seconds, or platelet count <50×10⁹/L; |
- Previous history of severe pancreatitis or severe delirium tremens;
Show all 12Show fewer
- In the investigator's judgment, the subject has any severe/uncontrolled systemic disease (e.g., respiratory, circulatory, digestive, nervous, hematological, urogenital, endocrine systems) or mental illness (e.g., major depressive disorder, schizophrenia, bipolar disorder, etc.) or other major diseases that the investigator believes would prevent providing informed consent, make participation in the study unsafe, complicate the interpretation of study outcome data, or otherwise affect the achievement of study objectives;
- Likely to require hospitalization or surgery during the study period, including planned elective surgery or hospitalization that cannot be postponed;
- Diagnosed with substance use disorder (other than alcohol) according to DSM-5 criteria within the current (within one year prior to randomization/administration) period, such as: benzodiazepines, amphetamines, opioids, or cocaine, etc.; |
- Used medications for relapse prevention (e.g., naltrexone, etc.) or received systematic psychological support therapy within 30 days prior to randomization/administration;
- Currently receiving treatment for opioid, amphetamine, alcohol, or other substance use disorders, or received opioids within 7 days prior to randomization/administration, likely to require opioid treatment during the study period, or positive urine test for opioids, marijuana, amphetamines, etc., or positive naloxone challenge test on the day of randomization/administration; 12. Allergy to the investigational drug or its excipients (polylactic acid, magnesium stearate), or local anesthetics; |
- 13. Currently participating in any investigational drug or device study, or used any investigational drug or device within 30 days prior to randomization/administration; 14. Skin infection at the implantation site or systemic skin disease judged to potentially affect the efficacy and safety evaluation of the investigational drug; | 15. Clinical or laboratory evidence of Human Immunodeficiency Virus (HIV) or syphilis carrier/infection. |
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University Address: No. 139, Renmin Road Central, Changsha City
Changsha, Hunan, 410011
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of Naltrexone Implant in Patients With Alcohol Use Disorder
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The study plans to enroll 210 adult patients with alcohol use disorder. After signing the informed consent form and undergoing screening based on inclusion/exclusion criteria, eligible participants will be randomly assigned to the low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling), high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling), and control group (placebo + general supportive psychological counseling) in a 1:1:1 ratio. On Day 0, participants will receive a single subcutaneous abdominal incision implantation with either 0.9 g or 1.5 g of naltrexone implant or placebo. Efficacy assessment will follow up to 24 weeks after randomization/dosing, while safety assessment will follow up to 48 weeks. There will be a total of 13 follow-up visits. Except for Day 3 (Visit 3) and Week 36 (Visit 12), which are telephone follow-ups, all other visits will be outpatient follow-ups. The first 24 weeks of the study will be double-blind. After completing the Week 24 follow-up, all participants will undergo efficacy assessment. Then they will enter the open-label observation period, followed up until Week 48.
- Conditions
- AUD
- Being tested
- low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling), high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling), control group (placebo + general supportive psychological counseling)
- Keywords
- naltrexone implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling)Drug
low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling)
high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)Drug
high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)
control group (placebo + general supportive psychological counseling)Other
control group (placebo + general supportive psychological counseling)
| Study group | Role | What they receive |
|---|---|---|
| low-dose group (naltrexone implant 0.9 g ) | Experimental | Not described Receives: Drug: low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) |
| high-dose group (naltrexone implant 1.5 g ) | Experimental | Not described Receives: Drug: high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling) |
| control group (placebo ) | Placebo comparator | Not described Receives: Other: control group (placebo + general supportive psychological counseling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of heavy drinking days during the 24-week observation period post-randomization/treatment
The "Heavy Drinking Days" are divided by the "Days at Risk of Heavy Drinking", with both calculations ending at the cessation of efficacy observation. "Days at Risk of Heavy Drinking" refers to the number of days participants receive efficacy observation during the study. Drinking rates are assessed based on daily alcohol consumption records completed by participants and their families, using the Timeline Follow-Back (TLFB) method. Heavy drinking is defined as "≥5 standard drinks per day for males and ≥4 standard drinks per day for females (In this trial, 1 standard drink = 10 g of pure alcohol).
Measured: 24-week
Secondary outcomes (11)
Change in number of heavy drinking days per month relative to baseline
Specifically, the comparison of total monthly heavy drinking days from randomization/drug administration to the end of follow-up/trial completion with baseline monthly heavy drinking days [calculate monthly corresponding data for weeks 1-24 after randomization/drug administration]; alcohol consumption rate is assessed using the Timeline Follow-Back (TLFB) method based on daily alcohol consumption records completed by subjects and their families . Heavy drinking is defined as "≥5 standard drinks per day for males and ≥4 standard drinks per day for females (in this trial, 1 standard drink = 10 g of pure alcohol).
Measured: 24-week
Alcohol-free days percentage
The "number of alcohol-free days" is divided by the "number of days at risk of alcohol consumption", with both calculations ending at the cessation of efficacy observation. The "number of days at risk of alcohol consumption" is defined as the number of days during which participants receive efficacy observation in the study. According to the Time-Line Follow-Back (TLFB) method, this is calculated based on alcohol consumption records; alcohol consumption is defined as any recorded alcohol consumption behavior, regardless of the quantity or frequency of consumption.
Measured: 24-week
Maximum Consecutive Days of Abstinence
The longest period of continuous alcohol abstinence from randomization/dosing to loss of follow-up/study completion; calculated based on daily alcohol consumption records completed by subjects and their families using the Timeline Follow-Back (TLFB) method.
Measured: 24-week
Daily and Weekly Alcohol Consumption (Daily Drinking Amount and Weekly Total Drinking Amount)
Daily drinking amount and weekly total drinking amount for the corresponding period; calculated based on weekly data from 1 to 24 weeks after randomization/dosing; calculated using the TLFB method based on daily drinking records completed by subjects and their families.
Measured: 24-week
Alcohol Breath Concentration
Random/Post-dosing at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks; measured by digital alcohol breath tester.
Measured: 24-week
Alcohol Craving Assessment
Randomized/Post-treatment scores at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks; assessed using Visual Analogue Scale (VAS). VAS assessment: One end of the horizontal line is "0", indicating no craving at all; the other end is "10", indicating extreme craving; the middle section represents varying degrees of craving. Participants are asked to select a number from 0-10 that represents their level of craving based on self-perception. The higher the number, the greater the degree of craving.
Measured: 24-week
Alcohol Consequences Score
Randomized/Post-treatment at weeks 4, 8, 12, 16, 20, and 24; assessed using the Alcohol Consequences Checklist
Measured: 24-week
Individual and Social Functioning Status
Assessment of individual and social functioning status at random/4, 8, 12, 16, 20, and 24 weeks post-treatment; Evaluated based on the Personal and Social Performance (PSP) scale:
A total score of 71-100 indicates no difficulty or only mild difficulty in social functioning and interpersonal relationships A total score of 31-70 indicates varying degrees of impairment in social functioning and interpersonal relationships A total score below 30 indicates poor functioning, requiring active support or close supervision
Measured: 24-week
Follow-up duration (from randomization/dosing to last follow-up)
defined as the time from randomization/dosing to the last follow-up visit.
Measured: 24-week
The proportion of subjects with poor treatment response
defined as the proportion of subjects who were hospitalized for alcohol withdrawal, picked up medication, or lost to follow-up due to poor treatment response;"lost to follow-up due to poor treatment response" is defined as having ≥2 heavy drinking days per week in the 4 weeks prior to loss to follow-up.
Measured: 24-week
Safety assessment indicators
including adverse events (AE) and serious adverse events (SAE) (including local AE and SAE at the implant site), abnormal occurrences of vital signs, physical examination, 12-lead or more ECG, and laboratory safety data (blood routine, urine routine, clinical biochemistry, and coagulation routine) before and after treatment.
Measured: 48-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start3 Apr 2023
- Primary completion27 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AUDStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333638
- Sponsor's protocol ID
- SK2007-NQT-201
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of Naltrexone Implant in Patients With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07333638
- Acronym / sponsor ID
- SK2007-NQT-201
- Conditions
- AUD
- Keywords
- naltrexone implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 12 Jan 2026 (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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The study plans to enroll 210 adult patients with alcohol use disorder. After signing the informed consent form and undergoing screening based on inclusion/exclusion criteria, eligible participants will be randomly assigned to the low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling), high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling), and control group (placebo + general supportive psychological counseling) in a 1:1:1 ratio. On Day 0, participants will receive a single subcutaneous abdominal incision implantation with either 0.9 g or 1.5 g of naltrexone implant or placebo. Efficacy assessment will follow up to 24 weeks after randomization/dosing, while safety assessment will follow up to 48 weeks. There will be a total of 13 follow-up visits. Except for Day 3 (Visit 3) and Week 36 (Visit 12), which are telephone follow-ups, all other visits will be outpatient follow-ups. The first 24 weeks of the study will be double-blind. After completing the Week 24 follow-up, all participants will undergo efficacy assessment. Then they will enter the open-label observation period, followed up until Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose group (naltrexone implant 0.9 g ) | Experimental | Drug: low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) |
| high-dose group (naltrexone implant 1.5 g ) | Experimental | Drug: high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling) |
| control group (placebo ) | Placebo comparator | Other: control group (placebo + general supportive psychological counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the informed consent form; willing and able to comply with and complete all trial procedures; |
- Age ≥18 years at the time of signing the informed consent form; |
- Diagnosis of moderate or severe Alcohol Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (meeting four or more diagnostic criteria, see Appendix 1 for details); |
- Completed detoxification treatment and had no significant alcohol withdrawal symptoms for at least one week (≥7 days) prior to randomization/administration [Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score <7 points (see Appendix 2 for specific assessment method)]; |
- Able to provide Timeline Followback (TLFB) alcohol use information for the 2 weeks during detoxification and/or prior to screening; |
Key exclusion criteria (12 listed)
- The investigator judges that participation in this study is not in the best interest of the subject, or any other condition that would make it unsafe for the subject to participate in the study; |
- Pregnancy, positive pregnancy test for women of childbearing potential, or lactating women, including women of childbearing potential planning to become pregnant during the study period. Note: Women of childbearing potential here refer to women capable of becoming pregnant. Must meet the following criteria, regardless of sexual orientation or tubal ligation: 1) No hysterectomy or bilateral oophorectomy; or 2) Have not been naturally postmenopausal for more than 12 consecutive months (i.e., have had menses at any time in the preceding 12 consecutive months); |
- Significant abnormal liver function (e.g., AST or ALT >2 times the upper limit of normal) or liver failure [including but not limited to: ascites, prolonged prothrombin time, International Normalized Ratio (INR) ≥1.7, esophageal variceal disease] or hepatobiliary ultrasound shows results that significantly impact the judgment of the study drug's efficacy and safety; |
- Suffering from clinically uncontrolled active infectious diseases, such as active Hepatitis B [Hepatitis B surface antigen (HBsAg) positive and Hepatitis B virus (HBV) DNA copy number >1000 IU/ml], active Hepatitis C [Hepatitis C virus antibody positive and Hepatitis C virus (HCV)-RNA positive], etc.; |
- History of congenital bleeding disorders (e.g., hemophilia) or any clinically significant active bleeding, or platelet dysfunction, or prothrombin time (PT) exceeding the upper normal limit by more than 3 seconds, or platelet count <50×10⁹/L; |
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 |
|---|---|---|
| low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling)low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) | Drug | low-dose group (naltrexone implant 0.9 g ) |
| high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling) | Drug | high-dose group (naltrexone implant 1.5 g ) |
| control group (placebo + general supportive psychological counseling)control group (placebo + general supportive psychological counseling) | Other | control group (placebo ) |
Primary outcome
Proportion of heavy drinking days during the 24-week observation period post-randomization/treatment
Time frame: 24-week
The "Heavy Drinking Days" are divided by the "Days at Risk of Heavy Drinking", with both calculations ending at the cessation of efficacy observation. "Days at Risk of Heavy Drinking" refers to the number of days participants receive efficacy observation during the study. Drinking rates are assessed based on daily alcohol consumption records completed by participants and their families, using the Timeline Follow-Back (TLFB) method. Heavy drinking is defined as "≥5 standard drinks per day for males and ≥4 standard drinks per day for females (In this trial, 1 standard drink = 10 g of pure alcohol).
11 secondary outcomes
Change in number of heavy drinking days per month relative to baseline
Time frame: 24-week
Alcohol-free days percentage
Time frame: 24-week
Maximum Consecutive Days of Abstinence
Time frame: 24-week
Daily and Weekly Alcohol Consumption (Daily Drinking Amount and Weekly Total Drinking Amount)
Time frame: 24-week
Alcohol Breath Concentration
Time frame: 24-week
Alcohol Craving Assessment
Time frame: 24-week
Alcohol Consequences Score
Time frame: 24-week
Individual and Social Functioning Status
Time frame: 24-week
Follow-up duration (from randomization/dosing to last follow-up)
Time frame: 24-week
The proportion of subjects with poor treatment response
Time frame: 24-week
Safety assessment indicators
Time frame: 48-week
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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for AUD
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
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 2 study testing low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling) and high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling) in people with AUD, run by Shenzhen Sciencare Medical Industries Co., Ltd. at 1 site in China.
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 12 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 12 Jan 2026. 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 China. 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 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?
Proportion of heavy drinking days during the 24-week observation period post-randomization/treatment (time frame: 24-week). 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 12 Jan 2026.