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.

Condition	Treatment or Intervention	Phase
Interstitial Cystitis	Procedure: H&P; ECG; Blood tests; voiding diary; Cystoscopy	Phase II

Further Study Details: 

Expected Total Enrollment:  150

RATIONALE: Topical resiniferatoxin (RTX) administrated to the bladder may be effective in decreasing the symptoms associated with interstitial cystitis through its action on pain sensing neurons.

PURPOSE: Randomized, double-blind, placebo-controlled, Phase 2 trial to determine the safety and efficacy of RTX in patients with interstitial cystitis.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• 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
• Uterine, cervical, vaginal, or urethral cancer within the past 5 years before study entry
• History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis
• History of bladder tumors (benign or malignant)

Alaska
      Alaska Clinical Research Center, Anchorage,  Alaska,  United States
California
      Center for Urological Research, La Mesa,  California,  United States
      Atlantic Urological Medical Group, Long Beach,  California,  United States
      Citrus Valley Medical Research, Inc., Glendora,  California,  United States
      Stanford University Medical Center, Stanford,  California,  United States
Colorado
      dba Genitourinary Surgical Consultants, PC, Denver,  Colorado,  United States
      Colorado Gynecology & Continence Center, Denver,  Colorado,  United States
Connecticut
      The Connecticut Clinical Research Center-Urology Specialist, Waterbury,  Connecticut,  United States
Florida
      Advanced Research Institute, New Port Richey,  Florida,  United States
Georgia
      Georgia Urology, Atlanta,  Georgia,  United States
Indiana
      Urology of Indiana, LLC, Indianapolis,  Indiana,  United States
      Northeast Indiana Research, LLC, Fort Wayne,  Indiana,  United States
Kansas
      KU Medical Center Research Institute, Kansas City,  Kansas,  United States
Maryland
      University of Maryland, Baltimore,  Maryland,  United States
Michigan
      Michigan William Beaumont Hospital, Royal Oak,  Michigan,  United States
Missouri
      St. Louis Urological Surgeons, St. Louis,  Missouri,  United States
Nevada
      Michael Kaplan, MD, Ltd., Henderson,  Nevada,  United States
North Carolina
      The Urology Center, Greensboro,  North Carolina,  United States
Oklahoma
      Urologic Specialists of Oklahoma, Tulsa,  Oklahoma,  United States
Oregon
      Oregon Urology Specialists, Eugene,  Oregon,  United States
Pennsylvania
      Pennsylvania Graduate Hospital, Philadelphia,  Pennsylvania,  United States
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  United States
Texas
      Urology San Antonio, San Antonio,  Texas,  United States
Washington
      Integrity Medical Research, LLC, Seattle,  Washington,  United States

Study chairs or principal investigators

Lyn Frumkin, M.D., Ph.D.,  Study Director,  ICOS Corporation, (425) 415-5571, lfrumkin@icos.com   

Study ID Numbers:  JIC01
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2003
ClinicalTrials.gov Identifier:  NCT00056251
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08