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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00309088 |
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Date of registration:
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29/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
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Scientific title:
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FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00309088 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinically diagnosed as myasthenia gravis
- Those whose MG symptoms are well-controlled by the treatment with prednisone
- Steroid non-refractory Myasthenia Gravis: ?20mg and ?40mg / alternate day of steroid
dose required to maintain
Exclusion Criteria:
- Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
- Patients who received steroid pulse therapy, plasma exchange therapy, globulin
therapy or radiation therapy within 12 weeks prior to the initiation of test drug
- Patients who started the immunosuppressant therapy or increased the dose of
immunosuppressant within 12 weeks prior to the initiation of test drug.
- Patients who had undergone thymectomy within 24 weeks prior to the initiation of test
drug.
- Pancreatitis or diabetes
- Serum creatinine?1.5mg/dL
Age minimum:
16 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis
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Intervention(s)
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Drug: placebo
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Drug: tacrolimus
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Primary Outcome(s)
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Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
[Time Frame: 6 Months]
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Secondary Outcome(s)
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Total amount of steroid therapy (mg)
[Time Frame: 6 Months]
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QMG score;MG-ADL
[Time Frame: 6 Months]
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Success rate of achievement to the targeted steroid dose
[Time Frame: 6 Months]
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Secondary ID(s)
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F506-CL-0601
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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