Interstitial Cystitis
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Interstitial Cystitis
Intervention
H&P; ECG; Blood tests; voiding diary; Cystoscopy
Location
Alaska Clinical Research Center
Anchorage
Alaska
United States
Status
Completed
Source
ICOS Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00056251
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cystitis, Interstitial
A condition with recurring discomfort or pain in the URINARY BLADDER and the surrounding pelvic region without an identifiable disease. Severity of pain in interstitial cystitis varies greatly and often is accompanied by increased urination frequency and urgency.
Cystitis
Inflammation of the URINARY BLADDER, either from bacterial or non-bacterial causes. Cystitis is usually associated with painful urination (dysuria), increased frequency, urgency, and suprapubic pain.
Blood Coagulation Tests
Laboratory tests for evaluating the individual's clotting mechanism.
Clinical Chemistry Tests
Laboratory tests demonstrating the presence of physiologically significant substances in the blood, urine, tissue, and body fluids with application to the diagnosis or therapy of disease.
Pancreatic Function Tests
Tests based on the biochemistry and physiology of the exocrine pancreas and involving analysis of blood, duodenal contents, feces, or urine for products of pancreatic secretion.
Clinical Trials
A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.
Genetic Studies in Interstitial Cystitis
Interstitial cystitis (also called painful bladder syndrome, or chronic pelvic pain syndrome) is a common condition with no known cure. It is estimated that every 15 seconds, a person in t...
Events Preceding Interstitial Cystitis (EPIC)
EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC wit...
Relationship of Interstitial Cystitis to Vulvodynia
This study is important in urologic nursing since many patients have interstitial cystitis (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the Unite...
Urinary Biomarkers Characteristic to Interstitial Cystitis
This is a retrospective study of urine samples stored in the Beaumont BioBank for future research. The urine samples will be drawn from the urine back with patients previously diagnosed w...
PubMed Articles
PURPOSE: We evaluate the efficacy of hyaluronate acid instillation for treatment of interstitial cystitis (IC). PATIENTS AND METHODS: From March 2008 to May 2009, a prospective study included 31 patie...
PURPOSE: We characterized and compared the impact of clinical phenotypic associations between interstitial cystitis/painful bladder syndrome and controls in relation to potentially related conditions,...
OBJECTIVE: To find out the data of the micturitions in healthy young people with the remote & mobile voiding diary monitoring system. METHODS: Twenty healthy young people were studied and ten of them...
INTRODUCTION AND HYPOTHESIS: This study assesses the prevalence of interstitial cystitis (IC)/bladder pain syndrome (BPS) in women with chronic pelvic pain (CPP). METHODS: This was a prospective study...
Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation.
INTRODUCTION AND HYPOTHESIS: Interstitial cystitis is a multifaceted medical condition consisting of pelvic pain, urgency, and frequency. Can sacral neuromodulation be successfully utilized for the me...
