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This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Experimental | Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
|
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Other | Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiRIS® | Combination Product | LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis. | Baseline (Days -7 to 0) to Treatment 1 Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Till Geib | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| IC Study LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34288094 | Derived | Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20. |
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, plesase contact IR-CTRegistration@Allergan.com for assistance. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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| LiRIS Placebo | Combination Product | LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy. |
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| Escondido |
| California |
| 92025 |
| United States |
| Tower Urology | Los Angeles | California | 90048 | United States |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States |
| Genesis Research LLC | San Diego | California | 92123 | United States |
| Sutter Health | Vacaville | California | 95688 | United States |
| Women's Health Specialty Care | Farmington | Connecticut | 06032 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Manatee Medical Research Institute | Bradenton | Florida | 34205 | United States |
| Atlanta Medical Research Instititute | Alpharetta | Georgia | 30005 | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| Associated Surgeons and Physicians LLC DBA Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Anne Arundel Urology, P.A. | Annapolis | Maryland | 21401 | United States |
| Chesapeake Urology Research Associates | Baltimore | Maryland | 21237 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research | St Louis | Missouri | 63117 | United States |
| Cooper University Hospita/ Univeristy Urogynecology Associates | Voorhees Township | New Jersey | 08043 | United States |
| Western New York Urology Associates | Cheektowaga | New York | 14225 | United States |
| BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System | Lake Success | New York | 11042 | United States |
| Urology Institute of Long Island | Plainview | New York | 11803 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| Alliance Urology Specialist, P.A. | Greensboro | North Carolina | 27403 | United States |
| Eastern Urological Associates, PA | Greenville | North Carolina | 27834 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | United States |
| MetroHealth System | Cleveland | Ohio | 44109 | United States |
| Female Sexual and Pelvic Health Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Integrity Medical Research (Urology Northwest) | Mountlake Terrace | Washington | 98043 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Silverado Research Inc | Victoria | British Columbia | V8T 2C1 | Canada |
| Urology Associates/Urologic Medical Research | Kitchener | Ontario | N2N 2B9 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) |
Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| BG001 | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis. | Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1. | Posted | Least Squares Mean | 90% Confidence Interval | score on a scale | Baseline (Days -7 to 0) to Treatment 1 Week 4 |
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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 Placebo (Treatment Period 1) | Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. | 1 | 66 | 22 | 66 | ||
| EG001 | LiRIS® (Treatment Period 1) | Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. | 2 | 65 | 22 | 65 | ||
| EG002 | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. | 1 | 48 | 4 | 48 | ||
| EG003 | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. | 0 | 50 | 7 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Pelvic congestion | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Urethral pain | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Bladder discomfort | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Personal Reasons |
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| ≥ 40 Years |
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| Male |
|