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NCT01786655 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Long-Acting Local Anesthetic
A Phase 1 study of Safety of Neosaxitoxin in Healthy Volunteers, sponsored by Charles Berde.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT01786655: Completed Phase 1 study of Safety of Neosaxitoxin in Healthy Volunteers, sponsored by Charles Berde.
NCT01786655 is a Phase 1 study of Safety of Neosaxitoxin in Healthy Volunteers that has completed, run by Charles Berde. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01786655, a Phase 1 study of Safety of Neosaxitoxin in Healthy Volunteers, has completed, sponsored by Charles Berde.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection in combination with the commonly used local anesthetic, bupivacaine, and epinephrine. The investigators hypothesize that a "minimal adverse effect threshold" NeoSTX dose for subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml respectively, can be defined for awake, young adult healthy volunteer subjects. At the same time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.
Conditions Studied
Interventions
- DRUG Neosaxitoxin in saline
- DRUG NeoSTX + bupivacaine 0.2%
- DRUG NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml
- OTHER Saline placebo
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01786655 record still lists
NCT01786655 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Safety of Neosaxitoxin in Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Neosaxitoxin in saline is the first listed.
NCT01786655 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01786655 about?
NCT01786655 is a clinical study titled "Safety Study of Long-Acting Local Anesthetic". The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection in combination with the commonly used local anesthetic, bupivacaine, and epinephrine. The investigators hypothesize that a ...
What is the current status of trial NCT01786655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2013-05. Estimated completion is 2014-04.
What conditions does trial NCT01786655 study?
This clinical trial studies the following conditions: Safety of Neosaxitoxin in Healthy Volunteers.
What interventions are being tested in trial NCT01786655?
The interventions under investigation include: Neosaxitoxin in saline (DRUG), NeoSTX + bupivacaine 0.2% (DRUG), NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml (DRUG), Saline placebo (OTHER).
Who is sponsoring clinical trial NCT01786655?
This trial is sponsored by Charles Berde, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01786655 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01786655's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 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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