CystitisPhase 2NCT06391164
Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
A Phase 2 study testing XC243 25 mg, XC243 50 mg and XC243 75 mg in people with Cystitis, run by PHARMENTERPRISES LLC at 8 sites in Russia.
Trial summary
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cystitis
- What is being tested?
- XC243 25 mg, XC243 50 mg and XC243 75 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 8 sitesRussia
- Study dates
- Apr 2024to Dec 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of the Form signed and dated by the patient the Patient Information Leaflet informed consent (IMP).
- Women aged 18 to 65 years inclusive at the time of signing the Informed IMP consent.
- Established diagnosis of chronic bacterial cystitis (at least three relapses chronic cystitis within 12 months prior to screening or two cases within 6 months prior to screening, including relapse at study entry).
- The presence of symptoms characteristic of exacerbation of chronic cystitis: pain syndrome (pain in lower abdomen, when urinating), dysuric symptoms (increased urination, pain or burning when urinating, urgency to urinate, feeling of incomplete emptying bladder).
- The appearance of symptoms of exacerbation of chronic cystitis is not > 48 hours prior to screening visit.
- Severity of the symptom "Pain, discomfort or burning with urination "from 4 to 8 VAS points.
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- No therapy for current cystitis exacerbation (including phosphomycin and/or furasidin for the treatment of current exacerbation).
- The patient's consent to refrain from drinking alcoholic beverages during the period of participation in study.
- Patient consent to use reliable methods contraception throughout the study and through 3 weeks after its end.
Who cannot join
- Hypersensitivity to the active and/or any of excipients of the test drug.
- Hypersensitivity to furasidine and/or any of the excipients concomitant medication.
- Chronic recurrent cystitis due to infections, sexually transmitted diseases (STIs): gonorrhea, chlamydia, ureaplasmosis, mycoplasmosis, herpes, candidiasis, gardnerellosis, history of trichomoniasis.
- Chronic recurrent cystitis of viral etiology (caused by adenovirus, cytomegalovirus, virus human papillomavirus herpes).
- Axillary body temperature ≥ 38 ° C at the screening visit.
- Presence of menstruation at randomization or estimated onset of menstruation during the period therapy.
Show all 30Show fewer
- Pain in the lumbar region.
- Itching and abundant vaginal discharge and/or purulent discharge from the genitourinary tract.
- History and/or findings of genitourinary anatomical disorders ultrasound examination (hydronephrosis, sclerosis of the bladder neck, cystocele, descent uterus, paraurethral cyst).
- Presence of inflammatory diseases of the sexual system (vaginitis, colpitis, cervicitis).
- Kidney and urinary tract diseases (including urolithiasis), with the exception of chronic cystitis, with a history that, in the opinion of study doctor, may affect the course and results of the clinical study.
- Chronic renal failure.
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
- History of pseudomembranous colitis.
- Signs of macrohematuria (admixture of blood in the urine, discoloration of the urine).
- Previous urinary tract surgery or radiation therapy.
- History of malignancy, per excluding patients who have not had disease within the last 5 years, patients with completely cured basal cell carcinoma or completely cured carcinoma in situ.
- Patients with HIV, syphilis, hepatitis B and C diseases, including a history.
- Liver disease that the study doctor believes may affect course and outcomes clinical trial, history of hepatic failure.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, and also make it impossible to conduct clinical trial with this patient).
- Use of analgesic drugs activity, including systemic NSAIDs, as well as antispasmodic drugs less than 24 hours before taking study drug/placebo.
- No history of efficacy of furasidine and/or no data furasidin sensitivity based on a history of urine microbiology.
- The need for the use of drugs from the list of prohibited therapy.
- Use of systemic antibacterial drugs actions within 7 days prior to screening.
- Administration of other medicinal products which, in the opinion of the study doctor, may affect progress and results clinical trial.
- Participation in another clinical trial within 3 months prior to screening.
- Pregnancy or breastfeeding.
- Alcohol or drug dependence, history of mental illness.
- Patient unwillingness or inability to comply with procedures protocol (in the opinion of the study physician).
- Other conditions that prevent the patient from being included in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Unimed-S Cjsc
Moscow, 119571
Elena Volnaya, MD, +79165900601, drvolnaya@yandex.ru
LLC "Research Center Eco-Safety"
Saint Petersburg, 191119
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic № 112"
Saint Petersburg, 195427
Alexander Merzlyakov, MD, +79818629541, merzel88@mail.ru
LLC "Research Center Eco-Safety"
Saint Petersburg, 196143
Dmitriy Zlobin, MD, +79523851666, zlobin_ds@ecosafety.ru
LLC "Clinic Zvezdnaya"
Saint Petersburg, 196158
Alexander Bulkin, MD, +79533464851, alexander_bulkin@mail.ru
North-West Center of Evidence-Based Medicine Jsc
Saint Petersburg, 196158
Alexey Schmelev, MD, +79522648249, aludm2@mail.ru
Prime Rose Medical Center LLC
Saint Petersburg, 197374
Anton Boriskin, MD, PhD, +79112120980, flounder@yandex.ru
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"
Saint Petersburg, 199178
Michail Alexeev, MD, PhD, +79219503727, Alexeevmy@mail.ru
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo for 7-10 days. Efficacy will be assessed by time from first study treatment to resolution of the symptom "Pain, discomfort or burning when urination " assessed on a visual-analog scale (VAS).
Read the detailed description
The study will be conducted in 8 centers. The study will include the following periods: screening (1 day), treatment period (up to 10 days), follow-up period (7 days).
Upon completion of screening, patients will be randomized to 4 groups in the ratio 1:1:1:1: XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo group.
Also, all patients will be prescribed furasidin daily at the same time, 2 capsules (total dose 100 mg) 3 times a day after meals. On day 8 the investigator will assess the symptoms of cystitis and decide whether to discontinue or prolong a course of therapy with XC243 and furasidin for up to 10 days.
- Conditions
- Cystitis
- Being tested
- XC243 25 mg, XC243 50 mg, XC243 75 mg, Placebo
- Keywords
- Phase II, VAS
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC243 25 mgDrug
Patients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days
XC243 50 mgDrug
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
XC243 75 mgDrug
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
PlaceboDrug
Patients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days
| Study group | Role | What they receive |
|---|---|---|
| XC243 25 mg | Experimental | XC243 25 mg single Receives: Drug: XC243 25 mg |
| XC243 50 mg | Experimental | XC243 50 mg single Receives: Drug: XC243 50 mg |
| XC243 75 mg | Experimental | XC243 75 mg single Receives: Drug: XC243 75 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).
Symptom disappears (decreases) criterion "Pain, discomfort or burning during urination "is considered to be the simultaneous fulfillment of the following conditions: Improvement to 1 point or less in VAS and Maintain VAS score of 1 point or less for 24 hours. Within 96 hours (4 days) after the first dose of the IP assessment of the symptom "Pain, discomfort or burning when urinating" will be conducted by the patient after each urination. After 96 hours (from day 5) evaluation this symptom will be carried out 2 times a day (8-00 to 10-00 hours and from 20-00 to 22-00 hours over time).
Superiority over placebo will be considered established if difference in mean between groups (XC243 - placebo) by symptom reduction time would be greater than 11 hours at the time of treatment evaluation.
Measured: Day 1 - Day 10
Secondary outcomes (15)
Severity of the symptom "Pain, discomfort or burning with urination "as per VAS
Severity of the symptom "Pain, discomfort or burning with urination "as per VAS to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS.
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS to End of therapy Visit
Measured: Day 1 - Day 11
Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS).
ACSS assessment of disease symptoms to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Dynamics of typical symptoms according to the ACSS scale
Dynamics of typical symptoms of the disease according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Dynamics of quality of life according to the ACSS scale
Dynamics of quality of life according to the ACSS scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Frequency of patients with disappearance of all typical symptoms diseases
Frequency of patients with disappearance of all typical symptoms diseases (ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Time to disappearance of typical disease symptoms for each symptom by ACSS
Time to disappearance of typical disease symptoms (score 0 on the ACSS scale) for each symptom to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or urinary burning " by ACSS
Frequency of patients with disappearance of the symptom "pain or urinary burning "(ACSS score 0) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) " by ACSS
Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) "(score 0 according to ACSS) to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Scale score by Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Scale)
Scale score by PUF Scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Dynamics of symptoms of the disease according to the Diary patient.
Dynamics of symptoms of the disease according to the Diary patient to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose
Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose
Measured: Day 1 - Day 2
Mean urinary frequency per day by Patient Diary
Mean urinary frequency per day by Patient Diary to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11)
Measured: Day 1 - Day 11
Assesment by Global Clinical Impression Scale score (CGI-i)
Patient's CGI-i score
Measured: Day 1 - Day 11
Evaluation of the efficacy of therapy by 5 rating scale
Evaluation of the efficacy of therapy by 5 rating scale to Visit 2 (Day 2), Visit 3 (Day 5), Visit 4 (Day 8), End of therapy Visit (Day 11). This scale is assessed by the investigator, where 1 point - absence, 2 points - regression, 3 points - decrease in severity, 4 points - lack of positive dynamics, 5 points - increase in the main clinical symptoms
Measured: Day 1 - Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies 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
- Model description
- Parallel proup
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391164
- Sponsor's protocol ID
- PAIN-XC243-02-01-2023
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XC243 in Patients With Exacerbation of Chronic Cystitis
- ClinicalTrials.gov ID
- NCT06391164
- Acronym / sponsor ID
- PAIN-XC243-02-01-2023
- Conditions
- Cystitis
- Keywords
- Phase II, VAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of XC243 in patients with exacerbation of chronic cystitis. It is planned to include patients with chronic cystitis in 4 parallel groups, who will receive XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo for 7-10 days. Efficacy will be assessed by time from first study treatment to resolution of the symptom "Pain, discomfort or burning when urination " assessed on a visual-analog scale (VAS).
Detailed description
The study will be conducted in 8 centers. The study will include the following periods: screening (1 day), treatment period (up to 10 days), follow-up period (7 days).
Upon completion of screening, patients will be randomized to 4 groups in the ratio 1:1:1:1: XC243 at a dose of 25 mg per day, 50 mg per day, 75 mg per day or placebo group.
Also, all patients will be prescribed furasidin daily at the same time, 2 capsules (total dose 100 mg) 3 times a day after meals. On day 8 the investigator will assess the symptoms of cystitis and decide whether to discontinue or prolong a course of therapy with XC243 and furasidin for up to 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel proup
| Arm | Type | Receives |
|---|---|---|
| XC243 25 mg | Experimental | Drug: XC243 25 mgXC243 25 mg single |
| XC243 50 mg | Experimental | Drug: XC243 50 mgXC243 50 mg single |
| XC243 75 mg | Experimental | Drug: XC243 75 mgXC243 75 mg single |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Availability of the Form signed and dated by the patient the Patient Information Leaflet informed consent (IMP).
- Women aged 18 to 65 years inclusive at the time of signing the Informed IMP consent.
- Established diagnosis of chronic bacterial cystitis (at least three relapses chronic cystitis within 12 months prior to screening or two cases within 6 months prior to screening, including relapse at study entry).
- The presence of symptoms characteristic of exacerbation of chronic cystitis: pain syndrome (pain in lower abdomen, when urinating), dysuric symptoms (increased urination, pain or burning when urinating, urgency to urinate, feeling of incomplete emptying bladder).
- The appearance of symptoms of exacerbation of chronic cystitis is not > 48 hours prior to screening visit.
Key exclusion criteria (30 listed)
- Hypersensitivity to the active and/or any of excipients of the test drug.
- Hypersensitivity to furasidine and/or any of the excipients concomitant medication.
- Chronic recurrent cystitis due to infections, sexually transmitted diseases (STIs): gonorrhea, chlamydia, ureaplasmosis, mycoplasmosis, herpes, candidiasis, gardnerellosis, history of trichomoniasis.
- Chronic recurrent cystitis of viral etiology (caused by adenovirus, cytomegalovirus, virus human papillomavirus herpes).
- Axillary body temperature ≥ 38 ° C at the 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 |
|---|---|---|
| XC243 25 mgPatients will receive the Investigated Product (IP) once in the morning at least 30 minutes before eating for 7-10 days | Drug | XC243 25 mg |
| XC243 50 mgPatients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days | Drug | XC243 50 mg |
| XC243 75 mgPatients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days | Drug | XC243 75 mg |
| PlaceboPatients will receive the IP once in the morning at least 30 minutes before eating for 7-10 days | Drug | Placebo |
Primary outcome
Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases).
Time frame: Day 1 - Day 10
Symptom disappears (decreases) criterion "Pain, discomfort or burning during urination "is considered to be the simultaneous fulfillment of the following conditions: Improvement to 1 point or less in VAS and Maintain VAS score of 1 point or less for 24 hours. Within 96 hours (4 days) after the first dose of the IP assessment of the symptom "Pain, discomfort or burning when urinating" will be conducted by the patient after each urination. After 96 hours (from day 5) evaluation this symptom will be carried out 2 times a day (8-00 to 10-00 hours and from 20-00 to 22-00 hours over time). Superiority over placebo will be considered established if difference in mean between groups (XC243 - placebo) by symptom reduction time would be greater than 11 hours at the time of treatment evaluation.
15 secondary outcomes
Severity of the symptom "Pain, discomfort or burning with urination "as per VAS
Time frame: Day 1 - Day 11
Dynamics of the symptom "Pain, discomfort or burning when urinating" by VAS.
Time frame: Day 1 - Day 11
Assessment of disease symptoms by Acute Cystitis Symptom Score (ACSS).
Time frame: Day 1 - Day 11
Dynamics of typical symptoms according to the ACSS scale
Time frame: Day 1 - Day 11
Dynamics of quality of life according to the ACSS scale
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of all typical symptoms diseases
Time frame: Day 1 - Day 11
Time to disappearance of typical disease symptoms for each symptom by ACSS
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or urinary burning " by ACSS
Time frame: Day 1 - Day 11
Frequency of patients with disappearance of the symptom "pain or discomfort in the lower abdomen (suprapubic region) " by ACSS
Time frame: Day 1 - Day 11
Scale score by Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Scale)
Time frame: Day 1 - Day 11
Dynamics of symptoms of the disease according to the Diary patient.
Time frame: Day 1 - Day 11
Dynamics of the symptom "Pain or burning when urinating" according to VAS within first 24 hours post-dose
Time frame: Day 1 - Day 2
Mean urinary frequency per day by Patient Diary
Time frame: Day 1 - Day 11
Assesment by Global Clinical Impression Scale score (CGI-i)
Time frame: Day 1 - Day 11
Evaluation of the efficacy of therapy by 5 rating scale
Time frame: Day 1 - Day 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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.
8 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 XC243 25 mg, XC243 50 mg and XC243 75 mg in people with Cystitis, run by PHARMENTERPRISES LLC at 8 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 9 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Nebolsin (+79175584626, nve1970@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the first dose of IP treatment until the symptom "Pain, discomfort or burning when urination " disappears (decreases). (time frame: Day 1 - Day 10). 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 30 Apr 2024.