Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
NCT01075906 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG colchicine sprinkle capsules
Study Locations (10)
Tel Hashomer
- Safra Children's Hospital — Tel Litwinsky
- Sheba Medical Center — Tel Litwinsky
California
- Childrens Hospital Los Angeles — Los Angeles
Yerevan
- Center of Medical Genetics and Primary Health Care — Yerevan
Beer Sheba
- Soroka Medical Center — Beersheba
Haifa District
- Rambam Medical Center — Haifa
Israel
- Hadassah Medical Center — Jerusalem
Jerusalem
- Pediatric Rheumatology Unit - Shaare Zedek Medical Center — Jerusalem
Ankara
- Hacettepe University — Ankara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01075906
The ClinicalTrials.gov registry entry for NCT01075906 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mutual Pharmaceutical Company, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Familial Mediterranean Fever appearing as the primary indexed condition, and to 1 intervention — of which colchicine sprinkle capsules is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01075906 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Tel Hashomer, California, Yerevan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01075906 about?
NCT01075906 is a clinical study titled "Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients". 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 ...
What is the current status of trial NCT01075906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2010-08. Estimated completion is 2011-12.
What conditions does trial NCT01075906 study?
This clinical trial studies the following conditions: Familial Mediterranean Fever. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01075906?
The interventions under investigation include: colchicine sprinkle capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01075906?
This trial is sponsored by Mutual Pharmaceutical Company, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01075906 being conducted?
This trial has 10 study locations across California, Yerevan, Beer Sheba, Haifa District, Israel. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.