Safety Study of Long-Acting Local Anesthetic
Completed · Phase 1 · Has a placebo group
Conditions studied: Safety of Neosaxitoxin in Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT01786655
- Run by
- Charles Berde
- People needed
- 105
- Starts
- 2013-05-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2016-02-17
Who can join
Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy adult males ages 18-35
- ASA physical status 1 or 2
- English or Spanish speakers
- Must be able to come to Boston Children's Hospital for a 24-hour stay and able and willing to attend 5-10 study visits
- Must be able to provide informed consent
- Must be able to understand and perform all the procedures of the study including self-reporting of symptom scores
You may not qualify if…
- ASA physical status 3 or greater
- Cognitively challenged or other inability to understand the self-report measures or to give informed consent
- Significant cardiovascular, respiratory, neuromuscular disease or other systemic illness(es)
- No known or suspected allergies to neosaxitoxin, bupivacaine, or other local anesthetics
- Subjects may not be on any pain controlling medications, or any medications that would alter pain tolerance
- Subjects may not be on any medication that would alter cognition
- Subjects may not have any acute or chronic pain conditions requiring ongoing treatment or limiting daily activities
- No alcohol or illicit drug abuse
- No current smokers
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.