Clinical trial NCT01475253: Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Official title: A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 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: 2011-11-21
Enrollment: 104
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 purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

Detailed description: The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Eligibility criteria: Inclusion Criteria:

* Women age 18 and over
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able and willing to complete questionnaires and diary
* Able to comply with visit schedule including Day 14 Removal visit
* Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

* Pregnant or lactating women
* Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
* History or presence of any condition that would make it difficult to evaluate symptoms
* Did not complete blinded study (unblinded part of study only)

Primary outcomes:
measure: Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
timeFrame: Baseline, Day 7
measure: Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
timeFrame: Baseline, Day 14
measure: Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
timeFrame: Baseline, Day 28
measure: Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: Percentage of Responders Using the Global Response Assessment (GRA)
timeFrame: Baseline, Days 7, 14, 28 and 42
measure: Change From Baseline in Urinary Urgency as Assessed by VAS
timeFrame: Baseline, Days 7, 14, 28 and 42
measure: Change From Baseline in Voiding Frequency
timeFrame: Baseline, Days 7, 14, 28 and 42
measure: Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
timeFrame: Baseline, Days 7, 14, 28 and 42
measure: Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
timeFrame: Baseline, Days 7, 14, 28 and 42
measure: Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Clinical Trials of Arizona
state: Arizona
city: Glendora
country: United States
facility: Citrus Valley Medical Research, Inc
state: California
city: Stanford
country: United States
facility: Stanford University Department of Urology
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New Britain
country: United States
facility: Grove Hill Clinical Research
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Medical Research Institute, LLC
state: Florida
city: Coeur D'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Center
state: Idaho
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology LLC
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Jackson
country: United States
facility: CRC of Jackson and Southeast Urogynecology
state: Mississippi
city: Las Vegas
country: United States
facility: Sheldon Freedman, MD Ltd
state: Nevada
city: New Hyde Park
country: United States
facility: Arthur Smith Institute for Urology
state: New York
city: Rochester
country: United States
facility: University of Rochester, Department of Urology
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Penn. Presbyterian Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Urology Ambulatory Care
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
city: Victoria
country: Canada
facility: Pacific Urological Research
state: British Columbia
city: Kingston
country: Canada
facility: Centre for Applied Urologic Research/Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University/Kingston General Hospital/Ontario Canada
name: Curtis Nickel, MD
role: PRINCIPAL_INVESTIGATOR
References: