Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by:
ICOS Corporation
ClinicalTrials.gov Identifier:
NCT00056251
First received: March 7, 2003
Last updated: June 23, 2005
Last verified: January 2004
  Purpose

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 Intervention Phase
Interstitial Cystitis
Procedure: H&P; ECG; Blood tests; voiding diary; Cystoscopy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by ICOS Corporation:

Estimated Enrollment: 150
Study Start Date: January 2003
Estimated Study Completion Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056251

  Show 24 Study Locations
Sponsors and Collaborators
ICOS Corporation
Investigators
Study Director: Lyn Frumkin, M.D., Ph.D. ICOS Corporation, (425) 415-5571, lfrumkin@icos.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00056251     History of Changes
Other Study ID Numbers: JIC01
Study First Received: March 7, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by ICOS Corporation:
Interstitial Cystitis
Bladder

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014