Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
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ClinicalTrials.gov Identifier: NCT01075906 |
Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : January 10, 2012
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Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or crushing adult-dose tablets. An age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric patients. The primary objective of this study is to evaluate and compare the steady-state pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to pediatric and adult FMF patients.
Secondary objectives include evaluation of the safety and tolerability of this regimen in pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e, serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at baseline and after dosing.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Familial Mediterranean Fever | Drug: colchicine sprinkle capsules | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
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Experimental: Colchicine
Colchicine Sprinkle Capsules, 0.3 mg - dose administered according to age range on Day 1
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Drug: colchicine sprinkle capsules
0.3 mg |
Experimental: colchicine at steady state
colchicine sprinkle capsules 0.3 mg - dose administered according to age range on Day 15 following once daily dosing of colchicine on Days 2 - 14
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Drug: colchicine sprinkle capsules
0.3 mg |
- Maximum Plasma Concentration [ Time Frame: 15 days ]pharmacokinetic samples collected pre-dose on Days 1, 2 and 15 and at 0.25 - 0.5 hours, 1.5-2.5 hours and at 5-8 hours post-dose on Days 1 and 15
- Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t) [ Time Frame: 15 days ]Pharmacokinetic samples collected pre-dose on Days 1,2 and 15 and at 0.25-0.5 hours, 1.5-2.5 hours and 5-8 hours post-dose on Days 1 and 15.
- Area Under the Concentration Time Curve from Zero through Infinity [ Time Frame: 15 days ]Pharmacokinetic samples collected pre-dose on Days 1, 2 and 15 and at 0.25-0.5 hours, 1.5-2.5 hours and at 5-8 hours post-dose on Days 1 and 15
- Acute Phase Reactant (ESR, CRP, SAA) Levels [ Time Frame: 15 days ]Pharmacodynamic samples collected pre-dose on Days 7, 1 and 15

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Ages Eligible for Study: | 2 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075906
United States, California | |
Childrens Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
Armenia | |
Center of Medical Genetics and Primary Health Care | |
Yerevan, Armenia, 0010 | |
Israel | |
Soroka Medical Center | |
Beer Sheba, Israel, 84141 | |
Rambam Medical Center | |
Haifa, Israel, 24035 | |
Pediatric Rheumatology Unit - Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 | |
Hadassah Medical Center | |
Jerusalem, Israel, 91120 | |
Safra Children's Hospital | |
Tel Hashomer, Israel, 52621 | |
Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Turkey | |
Hacettepe University | |
Ankara, Turkey, 06100 | |
Cerrahpasa Medical Facility | |
Istanbul, Turkey, 34303 |
Study Chair: | Matthew Davis, MD | Mutual Pharmaceutical Company, Inc. |
Responsible Party: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT01075906 |
Other Study ID Numbers: |
MPC-006-09-1001 |
First Posted: | February 25, 2010 Key Record Dates |
Last Update Posted: | January 10, 2012 |
Last Verified: | January 2012 |
pharmacokinetics |
Brucellosis Familial Mediterranean Fever Hereditary Autoinflammatory Diseases Fever Body Temperature Changes Gram-Negative Bacterial Infections Bacterial Infections Genetic Diseases, Inborn Skin Diseases, Genetic |
Skin Diseases Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |