Clinical trial NCT01824303: Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Interstitial Cystitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: TARIS Biomedical, Inc.
First posted: 2013-04-04
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
timeFrame: Baseline, Day 12
Secondary outcomes:
measure: Change From Baseline in Total Daily Voids
timeFrame: Baseline, Day 27
measure: Change From Baseline in Night-Time Daily Voids
timeFrame: Baseline, Day 27
measure: Change From Baseline in Average Void Volume Per Micturition
timeFrame: Baseline, Day 27
measure: Change From Baseline in Post-Void Bladder Pain
timeFrame: Baseline, Day 27
measure: Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
timeFrame: Baseline, Day 27
measure: Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score
timeFrame: Baseline, Day 27
measure: Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
timeFrame: Baseline, Day 27
measure: Change From Baseline in Brief Pain Inventory (BPI)
timeFrame: Baseline, Day 27
Other outcomes:
Locations:
city: Glendora
country: United States
facility: Citrus Valley Medical Research , Inc.
state: California
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: The UrogynecologyCenter, LLC
state: Kansas
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology Institute of MI
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospitals
state: Michigan
city: New Hyde Park
country: United States
facility: North Shore - Long Island Jewish Heath System - Monter Cancer Center
state: New York
city: Newburgh
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group, University of Tennessee Medical Center
state: Tennessee
city: Abbotsford
country: Canada
facility: Exdeo Clinical Research Inc.
state: British Columbia
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
Study officials:
affiliation: Queen's University/Kingston General Hospital/Ontario Canada
name: Curtis Nickel, MD
role: PRINCIPAL_INVESTIGATOR
References: