Interstitial Cystitis

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056251
• Other study ID #: JIC01
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2003
• Last updated: June 23, 2005
• Start date: January 2003
• Est. completion date: August 2003

Study information

• Verified date: January 2004
• Source: ICOS Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Procedure:
• H&P; ECG; Blood tests; voiding diary; Cystoscopy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ICOS Corporation

Country where clinical trial is conducted

United States,