Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
- Conditions
- Interstitial Cystitis
- Interventions
- Other: LiRIS PlaceboDrug: LiRIS 400 mg
- Registration Number
- NCT01824303
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LiRIS Placebo LiRIS Placebo 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. LiRIS 400 mg LiRIS 400 mg 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) Baseline, Day 12 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Average Void Volume Per Micturition Baseline, Day 27 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.
Change From Baseline in Brief Pain Inventory (BPI) Baseline, Day 27 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.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score Baseline, Day 27 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.
Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) Baseline, Day 27 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.
Change From Baseline in Total Daily Voids Baseline, Day 27 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.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Baseline, Day 27 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.
Change From Baseline in Night-Time Daily Voids Baseline, Day 27 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.
Change From Baseline in Post-Void Bladder Pain Baseline, Day 27 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.
Trial Locations
- Locations (16)
North Shore - Long Island Jewish Heath System - Monter Cancer Center
🇺🇸New Hyde Park, New York, United States
Citrus Valley Medical Research , Inc.
🇺🇸Glendora, California, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Premier Medical Group of the Hudson Valley PC
🇺🇸Poughkeepsie, New York, United States
Alliance Urology Specialists, PA
🇺🇸Greensboro, North Carolina, United States
Centre for Applied Urological Research
🇨🇦Kingston, Ontario, Canada
William Beaumont Hospitals
🇺🇸Royal Oak, Michigan, United States
Female Pelvic Medicine & Urogynecology Institute of MI
🇺🇸Grand Rapids, Michigan, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
The UrogynecologyCenter, LLC
🇺🇸Overland Park, Kansas, United States
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Exdeo Clinical Research Inc.
🇨🇦Abbotsford, British Columbia, Canada
Volunteer Research Group, University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States