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Interstitial Cystitis

Sponsor
ICOS Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00056251
Collaborator
(none)
150
Enrollment
24
Locations
7
Duration (Months)
6.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: H&P; ECG; Blood tests; voiding diary; Cystoscopy
 Phase 2

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of RTX Topical Solution in Patients With Interstitial Cystitis
Study Start Date :
Jan 1, 2003
Study Completion Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Clinical Research Center Anchorage Alaska United States
    2 Citrus Valley Medical Research, Inc. Glendora California United States
    3 Center for Urological Research La Mesa California United States
    4 Atlantic Urological Medical Group Long Beach California United States
    5 Stanford University Medical Center Stanford California United States
    6 Colorado Gynecology & Continence Center Denver Colorado United States
    7 dba Genitourinary Surgical Consultants, PC Denver Colorado United States
    8 The Connecticut Clinical Research Center-Urology Specialist Waterbury Connecticut United States
    9 Advanced Research Institute New Port Richey Florida United States
    10 Georgia Urology Atlanta Georgia United States
    11 Northeast Indiana Research, LLC Fort Wayne Indiana United States
    12 Urology of Indiana, LLC Indianapolis Indiana United States
    13 KU Medical Center Research Institute Kansas City Kansas United States
    14 University of Maryland Baltimore Maryland United States
    15 Michigan William Beaumont Hospital Royal Oak Michigan United States
    16 St. Louis Urological Surgeons St. Louis Missouri United States
    17 Michael Kaplan, MD, Ltd. Henderson Nevada United States
    18 The Urology Center Greensboro North Carolina United States
    19 Urologic Specialists of Oklahoma Tulsa Oklahoma United States
    20 Oregon Urology Specialists Eugene Oregon United States
    21 Pennsylvania Graduate Hospital Philadelphia Pennsylvania United States
    22 Vanderbilt University Medical Center Nashville Tennessee United States
    23 Urology San Antonio San Antonio Texas United States
    24 Integrity Medical Research, LLC Seattle Washington United States

    Sponsors and Collaborators

    • ICOS Corporation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00056251
    Other Study ID Numbers:
    • JIC01
    First Posted:
    Mar 10, 2003
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jan 1, 2004
    Keywords provided by , ,
    Interstitial Cystitis
    Bladder
    Additional relevant MeSH terms:
    Cystitis
    Cystitis, Interstitial

    Study Results

    No Results Posted as of Jun 24, 2005