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| Name | Class |
|---|---|
| TARIS Biomedical, Inc. | INDUSTRY |
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The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiRIS® 400 mg | Experimental | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiRIS® 400 mg | Drug | LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. | Baseline, Day 14 |
| Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. | Baseline, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement. | Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advance Urology Institute | Daytona Beach | Florida | 32114 | United States | ||
| William Beaumont Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | LiRIS® 400 mg | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LiRIS® 400 mg | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. | Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. | Posted | Number | percentage of participants | Baseline, Day 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LiRIS® 400 mg | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement | Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12) |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | LiRIS® 400 mg | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
|
|
| Secondary | Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain | Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement. | Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12) |
|
|
|
| Secondary | Change From Baseline in Patient Reported IC Symptom: Daily Total Voids | The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement | Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up. | Posted | Mean | Standard Deviation | voids | Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12) |
|
|
|
| Primary | Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 | The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal. | Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. | Posted | Number | percentage of participants | Baseline, Day 28 |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Day 20 |
|
| Change from Baseline at Day 28 |
|
| Change from Baseline at Week 1 Follow-up |
|
| Change from Baseline at Week 2 Follow-up |
|
| Change from Baseline at Week 4 Follow-up |
|
| Change from Baseline at Week 8 Follow-up (n=5) |
|
| Change from Baseline at Week 12 Follow-up (n=5) |
|
| Title | Measurements |
|---|---|
|
| Change from Baseline at Day 20 |
|
| Change from Baseline at Day 28 |
|
| Change from Baseline at Week 1 Follow-up |
|
| Change from Baseline at Week 2 Follow-up |
|
| Change from Baseline at Week 4 Follow-up |
|
| Change from Baseline at Week 8 Follow-up (n=5) |
|
| Change from Baseline at Week 1 Follow-up (n=5) |
|
| Title | Measurements |
|---|---|
|
| Non-Responders |
|