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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01084278
The ClinicalTrials.gov registry entry for NCT01084278 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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