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

This study has been terminated.
(This study was terminated early due to company decision.)
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01824303
First received: March 31, 2013
Last updated: December 16, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Interstitial Cystitis
Drug: LiRIS 400 mg
Other: LiRIS Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) [ Time Frame: Baseline, Day 12 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Total Daily Voids [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 Night-Time Daily Voids [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 Average Void Volume Per Micturition [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 Post-Void Bladder Pain [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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 Brief Pain Inventory (BPI) [ Time Frame: Baseline, Day 27 ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: March 2013
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824303

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01824303     History of Changes
Other Study ID Numbers: TAR-100-202 
Study First Received: March 31, 2013
Results First Received: October 23, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 07, 2016