Cystitis, InterstitialPhase 2AMARANTHNCT01613586
A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
A Phase 2 study testing ASP3652 in people with Cystitis, Interstitial and Urinary Bladder Disease, run by Astellas Pharma Europe B.V. at 60 sites in 12 countries.
Trial summary
In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Interstitial, Urinary Bladder Disease, Pain
- What is being tested?
- ASP3652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 60 sitesin 12 countries
- Study dates
- 31 May 2012to 18 Mar 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has previously been diagnosed with BPS/IC; i.e., pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes
- Has at enrolment a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F-GUPI
- Has a mean pain score of 4.0 or greater on the 11-point (0-10) NRS for daily assessed pain (item 4 of F-GUPI-24H) over the last 7 days prior to randomization
- Is willing to comply with study requirements such as completing the questionnaires and diaries and attend all study visits and practicing birth control
Who cannot join
- Undergone a cystoscopy with hydrodistension or undergone Botox injections in the bladder within 6 months prior to screening
- Use of pentosan polysulphate sodium within 4 weeks prior to screening
- Any intravesicular pharmacological treatment or other interventions for BPS/IC or bladder, urethral, ureteral, pelvic or peri-pelvic invasive procedure within 3 months prior to screening
- Cystitis or documented symptomatic bacterial cystitis in the last 3 months prior to screening
- Lower urinary tract malignancy, such as positive (micro) hematuria in urine sediment
- Neurologic disease or defect affecting bladder function or symptomatic urethral diverticulum or any post-partum or surgery related genital tract conditions, symptomatic bladder or ureteral calculi or Post Void Residual volume greater than 150 mL
Show all 15Show fewer
- Clinically significant abnormalities observed during cystoscopy or on transabdominal ultrasound
- Currently active or treated sexual transmittable diseases
- Substance abuse or any use of delta-9-tertrahydrocannabinol (THC) as assessed by a positive urine test for THC at screening
- Any clinically relevant concomitant disease (past or present) which would, in the opinion of the investigator, put the subject at risk or mask measures of efficacy
- Symptoms of depression, defined as a Center for Epidemiological Studies Depression Scale score of 27 or more
- Use of steroids, immunomodulators, cytochrome P4502C8 inhibitors, cannabis / THC based medication, opioid analgesics or antiviral / antibacterial / antifungal agents during the last 4 weeks before the screening
- Initiation, discontinuation, or variation in the dose of antidepressants, anticonvulsants, antimuscarinics, benzodiazepines, skeletal muscle relaxants, non-steroid anti-inflammatory drugs, non opioid analgesics, homeopathic medication and herbal therapies during the last 4 weeks before the screening. Subjects should continue these medications at that same stable dose throughout the study
- Clinically relevant abnormal urine or blood safety laboratory values or active hepatic and/or biliary disease (AST or ALT should not be >2 times the upper limit of normal, total bilirubin should not be >1.5 times the upper limit of normal)
- Participated in any clinical study or has been treated with any investigational drug or device within 84 days or the period stipulated by local regulations, whichever is longer, prior to the screening
Trial locations and contacts
60 sites in 12 countries.
60 sites in 12 countries
Poland9 sites
Site: 5807
Bialystok, 15-224
Site 5806
Bydgoszcz, 85-094
Site: 5811
Chorzów, 41-500
Site: 5801
Lodz, 90-447
Site: 5805
Piaseczno, 05-500
Site: 5812
Poznan, 61-397
Site: 5802
Warsaw, 00-865
Site: 5804
Warsaw, 01-432
Site: 5803
Warsaw, 02-784
Germany8 sites
Site: 5406
Duisburg, 47179
Site: 5403
Emmendingen, 79312
Site: 5409
Frankfurt am Main, 60590
Site: 5402
Holzminden, 37603
Site 5410
Kirchheim, 73270
Site: 5405
Mainz, 55131
Site: 5404
Nürtingen, 72622
Site: 5414
Offenburg, 77654
Romania7 sites
Site 6006
Brasov, 500152
Site 6003
Bucharest, 0100-000
Site 6004
Bucharest, 021392
Site 6007
Bucharest, 022328
Site 6002
Bucharest, 042122
Site 6005
Iași, 700503
Site 6001
Târgu Mureş, 540103
Czechia6 sites
Site: 5202
Kralove, 500 05
Site: 5203
Kroměříž, 767 55
Site: 5206
Olomouc, 775 20
Site: 5209
Pilsen, 301 00
Site: 5210
Sternberk, 785 01
Site: 5201
Uherské Hradiště, 686 68
Russia6 sites
Site 6108
Moscow, 101000
Site 6103
Moscow, 105425
Site: 6111
Moscow, 115682
Site 6106
Moscow, 117997
Site 6101
Moscow, 127473
Site 6102
Saint Petersburg, 197022
Netherlands5 sites
Site: 5706
Amsterdam, 1081HV
Site: 5703
Maastricht, 6229 HX
Site: 5701
Nijmegen, 6525 GA
Site: 5702
Winterswijk, 7101 BN
Site: 5704
Zwijndrecht, 3331 LZ
Lithuania4 sites
Site: 6304
Kaunas, 50154
Site: 6302
Vilnius, 08661
Site: 6301
Vilnius, 09108
Site: 6303
Vilnius, 10207
Spain4 sites
Site 6203
Barcelona, 08024
Site 6201
Barcelona, 08850
Site 6202
Laguna, Tenerife, 38330
Site 6204
Málaga, 29009
Denmark3 sites
Site: 5303
Aarhus, 8200
Site: 5301
Herlev, 2730
Site: 5302
Næstved, 4700
Latvia3 sites
Site: 5602
Liepāja, 3401
Site: 5601
Riga, 1002
Site: 5603
Riga, 1038
Portugal3 sites
Site 5902
Coimbra, 3000-075
Site 5903
Porto, 4099-001
Site 5901
Porto, 4200-319
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of Female Patients With Bladder Pain Syndrome / Interstitial Cystitis
In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis.
Read the detailed description
This study consists of a screening phase, an initial 3 weeks Run-in period,
a 12 weeks Treatment period and a 2 weeks Follow-up (FU) period.
This study will investigate the efficacy and safety of a 12 week treatment with ASP3652 in female patients with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC). Different dose levels of ASP3652 will be compared with placebo. ASP3652 is administered as oral tablets. The objectives of the study are to investigate efficacy of ASP3652 in patients with BPS/IC, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with BPS/IC in an out-patient setting.
- Being tested
- ASP3652, Placebo
- Keywords
- ASP3652, Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome
- Medical subject headings
- Cystitis, Interstitial, Urinary Bladder Diseases, Pain, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Low dose ASP3652 twice daily | Experimental | 50 mg twice daily for 12 weeks Receives: Drug: ASP3652 |
| Medium dose ASP3652 twice daily | Experimental | 150 mg twice daily for 12 weeks Receives: Drug: ASP3652 |
| High dose ASP3652 twice daily | Experimental | 300 mg twice daily for 12 weeks Receives: Drug: ASP3652 |
| Placebo | Placebo comparator | Matching placebo twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Mean Daily Pain (MDP) at 12 weeks
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the Female GenitoUrinary Pain Index (24 hours recall) (F-GUPI-24h)
Measured: Baseline and 12 weeks
Secondary outcomes (14)
Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the F-GUPI-24h
Measured: Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Female GenitoUrinary Pain Index (one week recall) (F-GUPI) Total score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Measured: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in F-GUPI Pain subscale score, Urinary subscale score, and Quality of Life Impact score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Measured: Baseline, 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment
Measured: Every day during the Run-in, Treatment and Follow-up post treatment periods
Change from baseline in questionnaires at 12 weeks treatment
Bladder Pain/IC Symptom Score; O'Leary-Sant IC Symptom \& Problem Index; Short form McGill pain questionnaire; Female Sexual Function Index; European Quality of Life questionnaire in 5 Dimensions
Measured: Baseline and 12 weeks treatment
Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment
GRA is assessed as change from baseline which is here start of Run-in period
Measured: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Voiding parameters (urinary frequency, urinary urgency, nocturia and total urgency score ) at 4, 8, 12 weeks treatment and at 2 weeks Follow-up post treatment
Measured: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline
Measured: Baseline, 4, 8 and 12 weeks treatment
Assessment of pharmacokinetics at week 4, 8 and 12
Plasma levels of ASP3652
Measured: 4, 8 and 12 weeks treatment
Assessment of pharmacodynamics at week 4, 8 and 12
Plasma levels of anandamides
Measured: 4, 8 and 12 weeks treatment
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs
Measured: Baseline and 12 weeks treatment
Safety as assessed by SteatoTest, adiponectin and PVR
Measured: Baseline and 12 weeks
Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment
Measured: Baseline and 12 weeks treatment
Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment
Measured: 12 weeks treatment and 2 weeks follow-up post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start31 May 2012
- Primary completion18 Mar 2014
- Study completion18 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis, InterstitialStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613586
- Sponsor's protocol ID
- 3652-CL-0018
- Other IDs
- 2011-004555-39
- Acronym
- AMARANTH
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2012
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of Female Patients With Bladder Pain Syndrome / Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT01613586
- Acronym / sponsor ID
- AMARANTH / 3652-CL-0018
- Keywords
- ASP3652, Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 31 May 2012 (actual)
- Primary completion
- 18 Mar 2014 (actual)
- Study completion
- 18 Mar 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis.
Detailed description
This study consists of a screening phase, an initial 3 weeks Run-in period,
a 12 weeks Treatment period and a 2 weeks Follow-up (FU) period.
This study will investigate the efficacy and safety of a 12 week treatment with ASP3652 in female patients with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC). Different dose levels of ASP3652 will be compared with placebo. ASP3652 is administered as oral tablets. The objectives of the study are to investigate efficacy of ASP3652 in patients with BPS/IC, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with BPS/IC in an out-patient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose ASP3652 twice daily | Experimental | Drug: ASP365250 mg twice daily for 12 weeks |
| Medium dose ASP3652 twice daily | Experimental | Drug: ASP3652150 mg twice daily for 12 weeks |
| High dose ASP3652 twice daily | Experimental | Drug: ASP3652300 mg twice daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has previously been diagnosed with BPS/IC; i.e., pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes
- Has at enrolment a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F-GUPI
- Has a mean pain score of 4.0 or greater on the 11-point (0-10) NRS for daily assessed pain (item 4 of F-GUPI-24H) over the last 7 days prior to randomization
- Is willing to comply with study requirements such as completing the questionnaires and diaries and attend all study visits and practicing birth control
Key exclusion criteria (15 listed)
- Undergone a cystoscopy with hydrodistension or undergone Botox injections in the bladder within 6 months prior to screening
- Use of pentosan polysulphate sodium within 4 weeks prior to screening
- Any intravesicular pharmacological treatment or other interventions for BPS/IC or bladder, urethral, ureteral, pelvic or peri-pelvic invasive procedure within 3 months prior to screening
- Cystitis or documented symptomatic bacterial cystitis in the last 3 months prior to screening
- Lower urinary tract malignancy, such as positive (micro) hematuria in urine sediment
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 |
|---|---|---|
| ASP3652Oral | Drug | High dose ASP3652 twice daily, Low dose ASP3652 twice daily, Medium dose ASP3652 twice daily |
| PlaceboOral | Drug | Placebo |
Primary outcome
Change from baseline in Mean Daily Pain (MDP) at 12 weeks
Time frame: Baseline and 12 weeks
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the Female GenitoUrinary Pain Index (24 hours recall) (F-GUPI-24h)
14 secondary outcomes
Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Female GenitoUrinary Pain Index (one week recall) (F-GUPI) Total score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in F-GUPI Pain subscale score, Urinary subscale score, and Quality of Life Impact score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment
Time frame: Every day during the Run-in, Treatment and Follow-up post treatment periods
Change from baseline in questionnaires at 12 weeks treatment
Time frame: Baseline and 12 weeks treatment
Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Voiding parameters (urinary frequency, urinary urgency, nocturia and total urgency score ) at 4, 8, 12 weeks treatment and at 2 weeks Follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline
Time frame: Baseline, 4, 8 and 12 weeks treatment
Assessment of pharmacokinetics at week 4, 8 and 12
Time frame: 4, 8 and 12 weeks treatment
Assessment of pharmacodynamics at week 4, 8 and 12
Time frame: 4, 8 and 12 weeks treatment
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs
Time frame: Baseline and 12 weeks treatment
Safety as assessed by SteatoTest, adiponectin and PVR
Time frame: Baseline and 12 weeks
Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment
Time frame: Baseline and 12 weeks treatment
Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: 12 weeks treatment and 2 weeks follow-up post treatment
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 5 Nov 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Clinical Study Manager study director
Astellas Pharma Europe B.V.
60 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP3652 in people with Cystitis, Interstitial and Urinary Bladder Disease, run by Astellas Pharma Europe B.V. at 60 sites in 12 countries.
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 4 inclusion and 15 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Poland, Germany, Romania, Czechia, Russia and 7 more countries. 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?
Change from baseline in Mean Daily Pain (MDP) at 12 weeks (time frame: Baseline and 12 weeks). 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 5 Nov 2024.