Healthy VolunteersPhase 1NCT00273065
Local Anesthetic Properties of Neosaxitoxin
A Phase 1 study testing Neosaxitoxin in people with Healthy Volunteers, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Neosaxitoxin
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- May 2005to Sep 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males with the abilities to understand and respond the tests to perform
Who cannot join
- Use of any oral analgesics at least ten days before the study
- Drugs abuse history
- Showing at the clinical examination any signal of psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Chile1 site
Henry Mayer Center, Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 0
About this study
Official title: Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
Read the detailed description
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial
Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.
- Conditions
- Healthy Volunteers
- Being tested
- Neosaxitoxin
- Keywords
- Local Anesthetic, Neosaxitoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeosaxitoxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural blockade of five parameters:
sensory threshold for warm
sensory threshold for cold
pain thresholds for heat
pain thresholds for cold
mechanical touch perception threshold
Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
Secondary outcomes (3)
Pain on injection (VAS Score 0-10)
Blood sample at 1 hour
Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMay 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Investigators
- Alberto Rodriguez-Navarro, MD, Principal investigator, University of ChileNestor Lagos, PhD, Principal investigator, Faculty of Medicine, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273065
- Sponsor's protocol ID
- HCUCH-AR-NEOSAX-0001
- Status last verified
- Feb 2007
- First submitted
- 4 Jan 2006
- Last updated
- 19 Feb 2007
- Results posted
- No
Publications
Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023.
PubMed 17264729
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic
- ClinicalTrials.gov ID
- NCT00273065
- Acronym / sponsor ID
- HCUCH-AR-NEOSAX-0001
- Conditions
- Healthy Volunteers
- Keywords
- Local Anesthetic, Neosaxitoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Sep 2005
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans
Detailed description
Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial
Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males with the abilities to understand and respond the tests to perform
Key exclusion criteria (3 listed)
- Use of any oral analgesics at least ten days before the study
- Drugs abuse history
- Showing at the clinical examination any signal of psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neosaxitoxin | Drug | – |
Primary outcome
Neural blockade of five parameters:
sensory threshold for warm
sensory threshold for cold
pain thresholds for heat
pain thresholds for cold
mechanical touch perception threshold
Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections
3 secondary outcomes
Pain on injection (VAS Score 0-10)
Blood sample at 1 hour
Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2007.
- Results publication: PubMed 17264729Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Rodriguez-Navarro, MD principal investigator
University of Chile
Nestor Lagos, PhD principal investigator
Faculty of Medicine, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neosaxitoxin in people with Healthy Volunteers, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural blockade of five parameters:. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2007.