Interstitial Cystitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of RTX Topical Solution in Patients With Interstitial Cystitis
1 other identifier
interventional
150
1 country
24
Brief Summary
Patients with interstitial cystitis who meet eligibility requirements will be randomized to one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single instillation within the urinary bladder. Study duration is 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2003
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 7, 2003
CompletedFirst Posted
Study publicly available on registry
March 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedJune 24, 2005
January 1, 2004
March 7, 2003
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age.
- Have IC that meets disease diagnostic criteria as defined by a history of the following:
- Cystoscopy/hydrodistension with a diagnosis of IC confirmed by findings of Hunner's ulcer or glomerulation
- Symptoms of bladder pain and urinary urgency for at least 6 months
- Urinary frequency while awake at least 8 times a day while awake
- Nocturia at least twice a night
- Symptoms not significantly relieved by antimicrobial agents, anticholinergic drugs, or antispasmodics
- Have IC that in the judgment of the investigator has been stable in the previous 30 days
- Have IC-related pain despite current therapy, defined as a score of 4 or greater \[(on a scale from 0 (none) to 9 (severe)\] on average over the past month and confirmed by the voiding diary collected at Visit 2
- Have at least one voided volume ≥ 75 cc in a 24 hour period, confirmed by the voiding diary collected at Visit 2
- Patients of childbearing potential must agree to use an acceptable form of contraception (oral contraceptives, intrauterine device or double barrier methods) from Visit 1 through Visit 6
- Provide signed informed consent
You may not qualify if:
- Currently pregnant or breastfeeding
- Presence of ulcers on the pre-treatment cystoscopy
- Intravesical therapy or bladder hydrodistention within the previous 60 days
- Initiation of pentosan polysulfate sodium (Elmiron®) within the previous 16 weeks
- Use of fentanyl patches, morphine sulfate, methadone or B\&O supprettes within the previous 30 days.
- Previous augmentation cystoplasty, cystectomy or cystolysis, neurectomy (i.e., hypogastric nerve plexus ablation) or implanted peripheral nerve stimulator which has affected bladder function
- History of ureteral reflux. Patients with a history of childhood urinary tract infections, recurrent urinary tract infections as an adult (defined as \>3 culture documented episodes within the previous 12 months), or pyelonephritis at any time must have a cystourethogram to rule out ureteral reflux.
- Evidence of renal impairment (creatinine \> 2 times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT \> 3 times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases
- Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results
- Treatment with a drug or medical device that has not received regulatory approval within the previous 30 days
- Investigators, study staff and their immediate families. Immediate family is defined as current spouse, parent, natural or legally adopted child (including a stepchild living in the investigator's household), grandparent, or grandchild.
- Previously completed or withdrawn from this study
- Urinary tract or prostatic infection within the past 3 months before study entry
- Active genital herpes or vaginitis
- Urethral diverticulum
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ICOS Corporationlead
Study Sites (24)
Alaska Clinical Research Center
Anchorage, Alaska, United States
Citrus Valley Medical Research, Inc.
Glendora, California, United States
Center for Urological Research
La Mesa, California, United States
Atlantic Urological Medical Group
Long Beach, California, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Gynecology & Continence Center
Denver, Colorado, United States
dba Genitourinary Surgical Consultants, PC
Denver, Colorado, United States
The Connecticut Clinical Research Center-Urology Specialist
Waterbury, Connecticut, United States
Advanced Research Institute
New Port Richey, Florida, United States
Georgia Urology
Atlanta, Georgia, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Urology of Indiana, LLC
Indianapolis, Indiana, United States
KU Medical Center Research Institute
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Michigan William Beaumont Hospital
Royal Oak, Michigan, United States
St. Louis Urological Surgeons
St Louis, Missouri, United States
Michael Kaplan, MD, Ltd.
Henderson, Nevada, United States
The Urology Center
Greensboro, North Carolina, United States
Urologic Specialists of Oklahoma
Tulsa, Oklahoma, United States
Oregon Urology Specialists
Eugene, Oregon, United States
Pennsylvania Graduate Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Urology San Antonio
San Antonio, Texas, United States
Integrity Medical Research, LLC
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lyn Frumkin, M.D., Ph.D.
ICOS Corporation, (425) 415-5571, lfrumkin@icos.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2003
First Posted
March 10, 2003
Study Start
January 1, 2003
Study Completion
August 1, 2003
Last Updated
June 24, 2005
Record last verified: 2004-01