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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: Completed Phase 1 study, sponsored by University of Minnesota.
NCT01749319 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
oral bioavailability is the fraction of an administered dose of unchanged drug that reaches the systemic circulation
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 |
What the finished NCT01749319 record still lists
NCT01749319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral baclofen is the first listed.
NCT01749319 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01749319's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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