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NCT01917825 · ClinicalTrials.gov registry record · Phase 2
A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
A Phase 2 study of Sciatica and Lumbosacral Radiculopathy, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 6
- Study locations
NCT01917825: Completed Phase 2 study of Sciatica and Lumbosacral Radiculopathy, sponsored by Medtronic Spinal and Biologics.
NCT01917825 is a Phase 2 study of Sciatica and Lumbosacral Radiculopathy that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 54 participants, below the 78-participant average among 6 other Sciatica trials with a reported enrollment target (31% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01917825, a Phase 2 study of Sciatica and Lumbosacral Radiculopathy, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.
Primary Outcome
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
Conditions Studied
Interventions
- DRUG MDT-15
Study Locations (6)
Indiana
- Indiana Spine Group - Carmel
- Franciscan St Francis Pain and Spine Center - Indianapolis
Florida
- Holy Cross Orthopedic Institute - Fort Lauderdale
Illinois
- Millennium Pain Center - Bloomington
Kentucky
- Otrimed Clinical Research - Edgewood
Missouri
- Pain and Rehabilitation Specialists - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT01917825 record still lists
NCT01917825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 78-participant average among 6 other Sciatica trials with a reported enrollment target (31% lower).
The record links to 2 conditions, with Sciatica appearing as the primary indexed condition, and to 1 intervention - of which MDT-15 is the first listed.
NCT01917825 lists 6 locations in 5 states (Indiana, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT01917825 about?
NCT01917825 is a clinical study titled "A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy". The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.
What is the current status of trial NCT01917825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-07. Estimated completion is 2016-10.
What conditions does trial NCT01917825 study?
This clinical trial studies the following conditions: Sciatica, Lumbosacral Radiculopathy.
What interventions are being tested in trial NCT01917825?
The interventions under investigation include: MDT-15 (DRUG).
Who is sponsoring clinical trial NCT01917825?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01917825 being conducted?
This trial has 6 study locations across Florida, Illinois, Indiana, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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