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Interstitial Cystitis

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
H&P; ECG; Blood tests; voiding diary; Cystoscopy
Sponsored by
ICOS Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Bladder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Alaska Clinical Research Center
  • Citrus Valley Medical Research, Inc.
  • Center for Urological Research
  • Atlantic Urological Medical Group
  • Stanford University Medical Center
  • Colorado Gynecology & Continence Center
  • dba Genitourinary Surgical Consultants, PC
  • The Connecticut Clinical Research Center-Urology Specialist
  • Advanced Research Institute
  • Georgia Urology
  • Northeast Indiana Research, LLC
  • Urology of Indiana, LLC
  • KU Medical Center Research Institute
  • University of Maryland
  • Michigan William Beaumont Hospital
  • St. Louis Urological Surgeons
  • Michael Kaplan, MD, Ltd.
  • The Urology Center
  • Urologic Specialists of Oklahoma
  • Oregon Urology Specialists
  • Pennsylvania Graduate Hospital
  • Vanderbilt University Medical Center
  • Urology San Antonio
  • Integrity Medical Research, LLC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2003
Last Updated
June 23, 2005
Sponsor
ICOS Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00056251
Brief Title
Interstitial Cystitis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ICOS Corporation

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Interstitial Cystitis, Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
H&P; ECG; Blood tests; voiding diary; Cystoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn Frumkin, M.D., Ph.D.
Organizational Affiliation
ICOS Corporation, (425) 415-5571, lfrumkin@icos.com
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
Country
United States
Facility Name
Citrus Valley Medical Research, Inc.
City
Glendora
State/Province
California
Country
United States
Facility Name
Center for Urological Research
City
La Mesa
State/Province
California
Country
United States
Facility Name
Atlantic Urological Medical Group
City
Long Beach
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
Country
United States
Facility Name
Colorado Gynecology & Continence Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
dba Genitourinary Surgical Consultants, PC
City
Denver
State/Province
Colorado
Country
United States
Facility Name
The Connecticut Clinical Research Center-Urology Specialist
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Georgia Urology
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Urology of Indiana, LLC
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
KU Medical Center Research Institute
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Michigan William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
St. Louis Urological Surgeons
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Michael Kaplan, MD, Ltd.
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Urologic Specialists of Oklahoma
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Oregon Urology Specialists
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Pennsylvania Graduate Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Interstitial Cystitis

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