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Trial record 34 of 1177 for:    MYCOPHENOLIC ACID

A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . . (ICCRN RCT2)

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ClinicalTrials.gov Identifier: NCT00451867
Recruitment Status : Terminated (The major and primary reason for the study termination is the observed reduced efficacy of CellCept compared to placebo.)
First Posted : March 26, 2007
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE March 23, 2007
First Posted Date  ICMJE March 26, 2007
Last Update Posted Date January 14, 2010
Study Start Date  ICMJE March 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
  • 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 ]
  • To assess the safety profile of CellCept in the treatment of refractory PBS/IC. [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2007)
  • To compare CellCept 2 grams daily to placebo for effects on overall IC symptoms and well being in patients with refractory PBS/IC.
  • To assess the safety profile of CellCept in the treatment of refractory PBS/IC.
Change History Complete list of historical versions of study NCT00451867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
  • 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 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 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 rate of detectable immune disorders in patients with PBS/IC refractory to standard treatment using CellCept. [ Time Frame: 12 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2007)
  • 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.
  • To assess the patterns of patient expectations, associations with symptom severity, and the potential impact of patient expectations on response to treatment.
  • 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.
  • To assess impact of study medication on pain medication use.
  • To assess the frequency and mechanism of unblinding on study results and assess how the patient's perception of which treatment they received changes over time and influences ultimate outcome.
  • To assess the rate of detectable immune disorders in patients with PBS/IC refractory to standard treatment using CellCept.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .
Official Title  ICMJE 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)
Brief Summary

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.

Detailed Description Interstitial Cystitis (IC) is a bladder syndrome characterized as painful, debilitating and chronic, with no universally successful treatment option currently available. Characteristic symptoms include pain with bladder filling, and marked urinary frequency (to relieve pain). The only FDA-approved oral medication for treatment of IC is pentosan polysulfate (Elmiron), recently demonstrated by our collaborative research network to perform with little more efficacy than placebo (ref), and which is expensive and has associated side effects. Current clinical treatment protocols are empiric and usually aimed at relieving pain. There is a pressing need for an effective oral medication for treatment of IC. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Painful Bladder Syndrome
Intervention  ICMJE
  • Drug: Mycophenolate Mofetil
    Other Name: CellCept
  • Drug: Mycofenolate Mofetil (MMF)
    2000 mg per day divided into 2 equal doses.
    Other Name: CellCept
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: A
    2000 mg per day of CellCept (MMF) divided into 2 equal doses.
    Interventions:
    • Drug: Mycophenolate Mofetil
    • Drug: Mycofenolate Mofetil (MMF)
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2007)
210
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00451867
Other Study ID Numbers  ICMJE DK765209-Cellcept (IND)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LeRoy M. Nyberg, PhD., MD, NIDDK
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP