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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: |
NCT01075906 |
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Date of registration:
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24/02/2010 |
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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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Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
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Scientific title:
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An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01075906 |
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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: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Armenia
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Israel
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Turkey
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United States
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Contacts
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Name:
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Matthew Davis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mutual Pharmaceutical Company, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients age 2-65 years with a confirmed clinical diagnosis of FMF,
- Non-pregnant, and
- If of child-bearing potential, using effective contraceptive measures.
Exclusion Criteria:
- Recent participation (within 30 days) in other research studies,
- Pregnant or lactating,
- History or current infection of human immunodeficiency virus (HIV), hepatitis A, B or
C,
- Current or recent use of any drugs/drug classes or combinations thereof that may
affect the absorption or metabolism of colchicine,
- Clinically relevant abnormal clinical laboratories at screening,
- Current or recent (<6 months) history of severe, unstable or uncontrolled
neurological, cardiovascular, gastrointestinal, hematological, moderate or severe
hepatic and/or renal disease, or evidence of other diseases at the physical
examination conducted at the screening.
Age minimum:
2 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Familial Mediterranean Fever
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Intervention(s)
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Drug: colchicine sprinkle capsules
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Primary Outcome(s)
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Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t)
[Time Frame: 15 days]
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Area Under the Concentration Time Curve from Zero through Infinity
[Time Frame: 15 days]
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Maximum Plasma Concentration
[Time Frame: 15 days]
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Secondary Outcome(s)
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Acute Phase Reactant (ESR, CRP, SAA) Levels
[Time Frame: 15 days]
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Secondary ID(s)
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MPC-006-09-1001
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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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