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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: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT02644421 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of subjects who report mild, moderate or severe treatment-emergent adverse events that are deemed by the investigator to be possibly, probably, or definitely related to the study medication
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 |
What the finished NCT02644421 record still lists
NCT02644421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02644421 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02644421's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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