Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01786655
The ClinicalTrials.gov registry entry for NCT01786655 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Charles Berde, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.