Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

• ClinicalTrials.gov Identifier: NCT01824303
• Recruitment Status: Terminated
• First Posted: April 4, 2013
• Results First Posted: November 26, 2015
• Last Update Posted: January 26, 2016
• Sponsor: Allergan
• Collaborator: TARIS Biomedical, Inc.
• Information provided by (Responsible Party): Allergan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis	Drug: LiRIS 400 mg; Other: LiRIS Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension
• Study Start Date: March 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: LiRIS 400 mg; LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
Placebo Comparator: 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.	Other: LiRIS Placebo; LiRIS Placebo contains lactose, inactive substance.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) [ Time Frame: 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 :

1. Change From Baseline in Total Daily Voids [ Time Frame: 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.
2. Change From Baseline in Night-Time Daily Voids [ Time Frame: 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.
3. Change From Baseline in Average Void Volume Per Micturition [ Time Frame: 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.
4. Change From Baseline in Post-Void Bladder Pain [ Time Frame: 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.
5. Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score [ Time Frame: 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.
6. Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score [ Time Frame: 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.
7. Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) [ Time Frame: 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.
8. Change From Baseline in Brief Pain Inventory (BPI) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

Blinded study:

• Women age 18 and over
• Diagnosed with Interstitial Cystitis as defined by protocol
• Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
• Able to comply with visit schedule and diary completion at home

Open-label Extension:

• Must have completed the blinded study prior to screening for the Open-label extension

Exclusion Criteria (Blinded and Open-Label Extension):

• Pregnant or lactating women
• History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
• Bladder or urethral abnormality that would prevent safe insertion of investigational product
• Requiring medication not allowed per study protocol

Contacts and Locations

Locations

United States, California

Citrus Valley Medical Research , Inc.

Glendora, California, United States, 91741

United States, Florida

Atlantic Urological Associates

Daytona Beach, Florida, United States, 32114

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

The UrogynecologyCenter, LLC

Overland Park, Kansas, United States, 66209-2002

United States, Michigan

Female Pelvic Medicine & Urogynecology Institute of MI

Grand Rapids, Michigan, United States, 49503

William Beaumont Hospitals

Royal Oak, Michigan, United States, 48073

United States, New York

North Shore - Long Island Jewish Heath System - Monter Cancer Center

New Hyde Park, New York, United States, 11040

Premier Medical Group of the Hudson Valley PC

Newburgh, New York, United States, 12550

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States, 12601

United States, North Carolina

Alliance Urology Specialists, PA

Greensboro, North Carolina, United States, 27403

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

United States, Tennessee

Volunteer Research Group, University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Canada, British Columbia

Exdeo Clinical Research Inc.

Abbotsford, British Columbia, Canada, V2S 3N6

Canada, Ontario

Centre for Applied Urological Research

Kingston, Ontario, Canada, K7L 3J7

Sponsors and Collaborators

Allergan

TARIS Biomedical, Inc.

Investigators

• Principal Investigator: Curtis Nickel, MD; Queen's University/Kingston General Hospital/Ontario Canada

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01824303
• Other Study ID Numbers: TAR-100-202
• First Posted: April 4, 2013
• Results First Posted: November 26, 2015
• Last Update Posted: January 26, 2016
• Last Verified: December 2015

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Urologic Diseases