Interstitial CystitisPhase 2NCT00056251
Interstitial Cystitis
A Phase 2 study testing H&P; ECG; Blood tests; voiding diary; Cystoscopy in people with Interstitial Cystitis, run by ICOS Corporation at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- H&P; ECG; Blood tests; voiding diary; Cystoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 24 sitesUnited States
- Study dates
- Jan 2003to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Alaska Clinical Research Center
Anchorage, Alaska
Georgia Urology
Atlanta, Georgia
University of Maryland
Baltimore, Maryland
Colorado Gynecology & Continence Center
Denver, Colorado
dba Genitourinary Surgical Consultants, PC
Denver, Colorado
Oregon Urology Specialists
Eugene, Oregon
Northeast Indiana Research, LLC
Fort Wayne, Indiana
Citrus Valley Medical Research, Inc.
Glendora, California
The Urology Center
Greensboro, North Carolina
Michael Kaplan, MD, Ltd.
Henderson, Nevada
Urology of Indiana, LLC
Indianapolis, Indiana
KU Medical Center Research Institute
Kansas City, Kansas
Center for Urological Research
La Mesa, California
Atlantic Urological Medical Group
Long Beach, California
Vanderbilt University Medical Center
Nashville, Tennessee
Advanced Research Institute
New Port Richey, Florida
Pennsylvania Graduate Hospital
Philadelphia, Pennsylvania
Michigan William Beaumont Hospital
Royal Oak, Michigan
Urology San Antonio
San Antonio, Texas
Integrity Medical Research, LLC
Seattle, Washington
St. Louis Urological Surgeons
St Louis, Missouri
Stanford University Medical Center
Stanford, California
Urologic Specialists of Oklahoma
Tulsa, Oklahoma
The Connecticut Clinical Research Center-Urology Specialist
Waterbury, Connecticut
About this study
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
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.
Read the 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.
- Conditions
- Interstitial Cystitis
- Being tested
- H&P; ECG; Blood tests; voiding diary; Cystoscopy
- Keywords
- Interstitial Cystitis, Bladder
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H&P; ECG; Blood tests; voiding diary; CystoscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2003 (estimated)
- Study startJan 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- ICOS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lyn Frumkin, M.D., Ph.D., Study director, ICOS Corporation, (425) 415-5571, lfrumkin@icos.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056251
- Sponsor's protocol ID
- JIC01
- Status last verified
- Jan 2004
- First submitted
- 7 Mar 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00056251
- Acronym / sponsor ID
- JIC01
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial Cystitis, Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- ICOS CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Aug 2003
- First posted
- 10 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H&P; ECG; Blood tests; voiding diary; Cystoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Interstitial Cystitis
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyn Frumkin, M.D., Ph.D. study director
ICOS Corporation, (425) 415-5571, lfrumkin@icos.com
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H&P; ECG; Blood tests; voiding diary; Cystoscopy in people with Interstitial Cystitis, run by ICOS Corporation at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.