Sponsor study identifier
interventional
105
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2013
Actual (reported)February 8, 2013
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 2014
Actual (reported)April 2014
Actual (reported)Presence or absence of Adverse Events as a function of NeoSTX dose
Within 14 days of injection
Pharmacokinetic parameters characterizing uptake and distribution of NeoSTX (content in serum and urine samples)
Within 24 hours of injection
Cutaneous sensory blockade (numbness)
Within 14 days of injection
Local skin reactions (edema, paresthesias and urticaria)
Within 14 days of injection
Subjects receive only one injection of NeoSTX in saline on the back of one calf (test side). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5mcg, 10mcg, 15mcg, 20mcg, 30mcg, and 40mcg NeoSTX.
Subjects receive only one injection of NeoSTX in combination with 0.2% bupivacaine on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg NeoSTX.
NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% alone on one side (control). On the other side they receive NeoSTX in saline (test). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX with 0.2% bupivacaine. Subjects receive NeoSTX in 0.2% bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordControl intervention
Saline placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordBoston Children's Hospital
Boston, Massachusetts, 02115, United States
Joseph Cravero, MD
Boston Children's Hospital
105 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2013
First Posted
February 8, 2013
Study Start
May 2013
Date type not reportedSubjects receive one injection of NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.
Subjects receive one injection of saline on the back of one calf (test side).
Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml. Subjects receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.
Each subject receives one injection with bupivacaine 0.2% alone on one side. On the other side they receive saline placebo.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
February 17, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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