Interstitial Cystitis

June 23, 2005 updated by: ICOS Corporation

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of RTX Topical Solution in Patients With Interstitial Cystitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICOS Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

March 7, 2003

First Submitted That Met QC Criteria

March 8, 2003

First Posted (Estimate)

March 10, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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