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NCT01749319 · ClinicalTrials.gov registry record · Phase 1
Oral and IV Baclofen in Adult Volunteers
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01749319 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 12 participants.
The verdict
NCT01749319, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation. This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.
Interventions
- DRUG Oral baclofen
- DRUG Intervenous baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749319
The ClinicalTrials.gov registry entry for NCT01749319 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oral baclofen is the first listed.
NCT01749319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01749319 about?
NCT01749319 is a clinical study titled "Oral and IV Baclofen in Adult Volunteers". The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation. This study is a randomized c...
What is the current status of trial NCT01749319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01749319?
The interventions under investigation include: Oral baclofen (DRUG), Intervenous baclofen (DRUG).
Who is sponsoring clinical trial NCT01749319?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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