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NCT01075906 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
A Phase 1 study of Familial Mediterranean Fever, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 10
- Study locations
NCT01075906: Completed Phase 1 study of Familial Mediterranean Fever, sponsored by Mutual Pharmaceutical Company.
NCT01075906 is a Phase 1 study of Familial Mediterranean Fever that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01075906, a Phase 1 study of Familial Mediterranean Fever, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
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
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 |
What the finished NCT01075906 record still lists
NCT01075906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
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.
NCT01075906 lists 10 locations in 9 states (Tel Hashomer, California, Yerevan).
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.
What interventions are being tested in trial NCT01075906?
The interventions under investigation include: colchicine sprinkle capsules (DRUG).
Who is sponsoring clinical trial NCT01075906?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT01075906's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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