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NCT02644421 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02644421 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 18 participants.
The verdict
NCT02644421, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (\>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
Interventions
- DRUG Placebo
- DRUG Lidocaine
- DRUG VVZ-149
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02644421
The ClinicalTrials.gov registry entry for NCT02644421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02644421 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02644421 about?
NCT02644421 is a clinical study titled "Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)". Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three sepa...
What is the current status of trial NCT02644421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-11. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02644421?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG), VVZ-149 (DRUG).
Who is sponsoring clinical trial NCT02644421?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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