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NCT01084278 · ClinicalTrials.gov registry record · Phase 4
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
A Phase 4 study of Pharmacokinetics, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01084278: Completed Phase 4 study of Pharmacokinetics, sponsored by Takeda.
NCT01084278 is a Phase 4 study of Pharmacokinetics that has completed, run by Takeda. The registered enrollment target is 40 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084278, a Phase 4 study of Pharmacokinetics, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.
Primary Outcome
The maximum or peak concentration of colchicine in the plasma.
Conditions Studied
Interventions
- DRUG Colchicine
Study Locations (1)
California
- West Coast Clinical Trials - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 4 |
What the finished NCT01084278 record still lists
NCT01084278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Colchicine is the first listed.
NCT01084278 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01084278 about?
NCT01084278 is a clinical study titled "Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)". The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and...
What is the current status of trial NCT01084278?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2010-05. Estimated completion is 2011-02.
What conditions does trial NCT01084278 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT01084278?
The interventions under investigation include: Colchicine (DRUG).
Who is sponsoring clinical trial NCT01084278?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01084278 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01084278's enrollment target sits among peer trials
40 9th of 37 higher than 26 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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.
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