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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00451867
Date of registration: 23/03/2007
Prospective Registration: No
Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Public title: A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . . ICCRN RCT2
Scientific title: 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)
Date of first enrolment: March 2007
Target sample size: 210
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00451867
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Canada United States
Contacts
Name:     Harris Foster, MD
Address: 
Telephone:
Email:
Affiliation:  Yale University
Name:     John Kusek, PhD
Address: 
Telephone:
Email:
Affiliation:  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Name:     Richard Landis, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Pennsylnania
Name:     David Burks, MD
Address: 
Telephone:
Email:
Affiliation:  Henry Ford Hospital
Name:     LeRoy Nyberg, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Painful Bladder Syndrome
Intervention(s)
Drug: Mycophenolate Mofetil
Drug: Placebo
Drug: Mycofenolate Mofetil (MMF)
Primary Outcome(s)
To assess the safety profile of CellCept in the treatment of refractory PBS/IC. [Time Frame: 12 Weeks]
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]
Secondary Outcome(s)
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]
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]
To assess impact of study medication on pain medication use. [Time Frame: 12 Weeks]
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]
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]
To assess the rate of detectable immune disorders in patients with PBS/IC refractory to standard treatment using CellCept. [Time Frame: 12 Weeks]
Secondary ID(s)
DK765209-Cellcept (IND)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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