- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451867
A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . . (ICCRN RCT2)
A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Mycophenolate Mofetil (CellCept) for the Treatment of Refractory Interstitial Cystitis (IC)
The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis.
CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants work in the body by reducing the immune system's ability to produce certain reactions that can cause inflammation. In some people, the inflammation produced by their immune system can damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant. When used in combination with other drugs, CellCept helps to prevent the rejection of the transplanted organ and is used widely in patients who have received kidney, liver and heart transplants. CellCept is also frequently used but not FDA approved for the treatment of severe rheumatoid arthritis which is a disease caused when the body's immune system acts against healthy tissues in the joints.
Due to its special activity, CellCept may be useful in treating certain inflammatory diseases or conditions like interstitial cystitis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L2V7
- Queen's University
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-
-
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California
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San Diego, California, United States, 92093
- Univeristy of California San Diego
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Stanford, California, United States, 94305
- Stanford University Medical Center
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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-
Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant at least 18 years of age and received a diagnosis of PBS/IC, confirmed by cystoscopy and hydrodistention in the past with findings of glomerulations and/or ulceration.
- Participant has symptoms of urinary frequency and pain/discomfort (at least 4 on each 0-10 Likert scale) at entry.
- Participant failed at least 24 weeks of active treatment with a minimum of 3 standard forms of therapy (including hydrodistension) or combination of therapies for PBS/IC.
- Participant will receive cystoscopy to be performed in the office at baseline visit before randomization if none has been conducted within the previous 24 weeks. Cystoscopy results must show no unevaluated lesions.
- Female participants with a cervix are required to have Pap smear exam within the past 12 months prior to enrollment with normal results reported.
- Participant (female) with child-bearing potential must agree to use two reliable/medically approved methods of birth control.
Exclusion Criteria:
- History of cancer or known pre-malignant conditions, including skin cancer.
- History of bladder calculus, tuberculous cystitis; neurologic disease affecting bladder function.
- Current immunocompromised condition, including current or chronic treatment with immunosuppressive agents, or known positive for HIV (positive antibody confirmed by Western Blot or IFA); active tuberculosis requiring on-going therapy; current systemic steroid treatment at any dose.
- Liver function test or creatinine results greater than 2x the upper limit of normal at home institution laboratory.
- Any baseline leukopenia (an absolute neutrophil count <1,500/µL), thrombocytopenia (a platelet count less than 150,000/microL), or anemia - HGB < 12 or < 11 g/dLin men and in women respectively.
- Is seropositive for Hepatitis B surface antigen; or is seropositive for Hepatitis B surface antibody (if not previously vaccinated); is seropositive for Hepatitis C antibody or HIV antigen or antibody.
- Allergy or hypersensitivity to study medication.
- Unable to void spontaneously.
- Active urethral or ureteral calculi, urethral diverticulum.
- Any severe debilitating or urgent concurrent medical condition.
- Previous cytoxan/cyclophosphamide treatment, pelvic radiation therapy; augmentation cystoplasty, cystectomy, or cystolysis; neurectomy.
- Participants with history of treatment for genital tract dysplasia or genital warts or genital herpes.
- Patients with active or a history of peptic ulcer disease, inflammatory bowel disease or gastrointestinal bleeding.
- Patients with hypertension not adequately controlled with medication.
- Patient currently taking H2 blockers or proton pump inhibitors.
- Patients who cannot tolerate or refuse an office cystoscopy.
Exclusion criteria for men only:
- Currently being treated for chronic bacterial prostatitis, as documented by a positive urine culture or prior history of recurrent bacterial urinary infections.
- Unevaluated suspicious prostate exam.
Exclusion criteria for women only:
- Lactation, pregnancy, or refusal of two types of (medically approved/reliable) birth control in women of child-bearing potential.
- Pain, frequency, urgency symptoms present only during menses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: B
Placebo
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Placebo
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Active Comparator: A
2000 mg per day of CellCept (MMF) divided into 2 equal doses.
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Other Names:
2000 mg per day divided into 2 equal doses.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare CellCept 2 grams daily to placebo for effects on overall IC symptoms and well being in patients with refractory PBS/IC.
Time Frame: 12 Weeks
|
12 Weeks
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To assess the safety profile of CellCept in the treatment of refractory PBS/IC.
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the association between clinical subgroups, characterized by differences in baseline characteristics (such as presence of ulcers, duration of symptoms, significant co-morbid diseases, serological abnormalities), and efficacy of CellCept.
Time Frame: 12 Weeks
|
12 Weeks
|
To assess the patterns of patient expectations, associations with symptom severity, and the potential impact of patient expectations on response to treatment.
Time Frame: 12 Weeks
|
12 Weeks
|
To assess patterns of treatment goals and goal achievement in this study population, as well as baseline characteristics and factors related to goal selection and achievement.
Time Frame: 12 Weeks
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12 Weeks
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To assess impact of study medication on pain medication use.
Time Frame: 12 Weeks
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12 Weeks
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To assess the frequency and mechanism of un-blinding on study results and assess how the patient's perception of which treatment they received changes over time and influences ultimate outcome.
Time Frame: 12 Weeks
|
12 Weeks
|
To assess the rate of detectable immune disorders in patients with PBS/IC refractory to standard treatment using CellCept.
Time Frame: 12 Weeks
|
12 Weeks
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Collaborators and Investigators
Investigators
- Study Director: John Kusek, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study Director: LeRoy Nyberg, MD, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Principal Investigator: Richard Landis, PhD, University of Pennsylnania
- Study Chair: David Burks, MD, Henry Ford Hospital
- Principal Investigator: Harris Foster, MD, Yale University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- interstitial cystitis research
- painful bladder syndrome research
- pelvic pain research
- interstitial cystitis and autoimmune
- interstitial cystitis and cellcept
- interstitial cystitis and mycophenolate mofetil
- interstitial cystitis and MMF
- interstitial cystitis and inflammation
- inflammatory diseases and immunosupression
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Cystitis
- Cystitis, Interstitial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Mycophenolic Acid
Other Study ID Numbers
- DK765209-Cellcept (IND)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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