Not provided
Not provided
Not provided
Not provided
Not provided
This study was terminated early due to company decision.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TARIS Biomedical, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.
The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg.
In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiRIS 400 mg | Experimental | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. |
|
| LiRIS Placebo | Placebo Comparator | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiRIS 400 mg | Drug | LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) | Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement. | Baseline, Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily Voids | Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement. | Baseline, Day 27 |
Not provided
Inclusion Criteria
Blinded study:
Open-label Extension:
Exclusion Criteria (Blinded and Open-Label Extension):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Curtis Nickel, MD | Queen's University/Kingston General Hospital/Ontario Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citrus Valley Medical Research , Inc. | Glendora | California | 91741 | United States | ||
| Atlantic Urological Associates |
31 participants signed the informed consent form and were enrolled in the study, 30 participants had the investigational product inserted and are included the Intent-to-treat Population.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LiRIS 400 mg | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. |
| FG001 | LiRIS Placebo | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LiRIS Placebo | Other | LiRIS Placebo contains lactose, inactive substance. |
|
| Change From Baseline in Night-Time Daily Voids |
Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement. |
| Baseline, Day 27 |
| Change From Baseline in Average Void Volume Per Micturition | Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement. | Baseline, Day 27 |
| Change From Baseline in Post-Void Bladder Pain | Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement. | Baseline, Day 27 |
| Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement. | Baseline, Day 27 |
| Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score | The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement. | Baseline, Day 27 |
| Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) | The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement. | Baseline, Day 27 |
| Change From Baseline in Brief Pain Inventory (BPI) | The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement. | Baseline, Day 27 |
| Daytona Beach |
| Florida |
| 32114 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| The UrogynecologyCenter, LLC | Overland Park | Kansas | 66209-2002 | United States |
| Female Pelvic Medicine & Urogynecology Institute of MI | Grand Rapids | Michigan | 49503 | United States |
| William Beaumont Hospitals | Royal Oak | Michigan | 48073 | United States |
| North Shore - Long Island Jewish Heath System - Monter Cancer Center | New Hyde Park | New York | 11040 | United States |
| Premier Medical Group of the Hudson Valley PC | Newburgh | New York | 12550 | United States |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | United States |
| Alliance Urology Specialists, PA | Greensboro | North Carolina | 27403 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27103 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Volunteer Research Group, University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Exdeo Clinical Research Inc. | Abbotsford British Columbia | British Columbia | V2S 3N6 | Canada |
| Centre for Applied Urological Research | Kingston | Ontario | K7L 3J7 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open Label Extension |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LiRIS 400 mg | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. |
| BG001 | LiRIS Placebo | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) | Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement. | Intent-to-treat (ITT) population included all randomized participants. | Posted | Mean | Standard Deviation | unit on a scale | Baseline, Day 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Daily Voids | Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | voids | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Night-Time Daily Voids | Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | voids | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Void Volume Per Micturition | Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | mL | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Post-Void Bladder Pain | Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score | The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 27 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) | The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 27 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Pain Inventory (BPI) | The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement. | Participants from the ITT population, all randomized participants, with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 27 |
|
|
Not provided
Not provided
Not provided
| 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_Randomized Study | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study. | 0 | 16 | 11 | 16 | ||
| EG001 | LiRIS Placebo_Randomized Study | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study. | 0 | 14 | 12 | 14 | ||
| EG002 | LiRIS 400 mg_Open Label Extension | LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension. | 0 | 12 | 6 | 12 | ||
| EG003 | LiRIS Placebo/LiRIS 400 mg _Open Label Extension | LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension. | 0 | 11 | 6 | 11 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder discomfort | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cystitis interstitial | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Residual urine volume increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urethritis noninfective | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
Due to technical issues with the patient electronic diary used for the collection of the outcome measures data, as well as the small evaluable sample size and large variability, the efficacy data should be interpreted with caution.
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 |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|