Local Anesthetic EffectivenessPhase 1NCT01032798
Local Anesthetics New Formulations: From Development to Clinical Tests
A Phase 1 study testing mepivacaine in people with Local Anesthetic Effectiveness, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetic Effectiveness
- What is being tested?
- mepivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to May 2008
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry
This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.
- Conditions
- Local Anesthetic Effectiveness
- Being tested
- mepivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mepivacaineDrug
One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency period and duration of anesthesia were assessed by an electrical pulp tester
Measured: 10 minutes
Secondary outcomes (1)
Plasma concentrations of mepivacaine
Measured: 0 to 360 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startMay 2007
- Study completionMay 2008
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 Local Anesthetic EffectivenessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Eneida de Paula, PHD, Study director, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032798
- Sponsor's protocol ID
- 06/00121-9
- Status last verified
- Apr 2007
- First submitted
- 15 Dec 2009
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tofoli GR, Cereda CM, Groppo FC, Volpato MC, Franz-Montan M, Ranali J, de Araujo DR, de Paula E. Efficacy of liposome-encapsulated mepivacaine for infiltrative anesthesia in volunteers. J Liposome Res. 2011 Mar;21(1):88-94. doi: 10.3109/08982104.2010.483596. Epub 2010 May 20.
PubMed 20482446
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry
- ClinicalTrials.gov ID
- NCT01032798
- Acronym / sponsor ID
- 06/00121-9
- Conditions
- Local Anesthetic Effectiveness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2007
- Study completion
- May 2008 (actual)
- First posted
- 16 Dec 2009 (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.
This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
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 |
|---|---|---|
| mepivacaineOne intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine. | Drug | – |
Primary outcome
Latency period and duration of anesthesia were assessed by an electrical pulp tester
Time frame: 10 minutes
1 secondary outcome
Plasma concentrations of mepivacaine
Time frame: 0 to 360 minutes after the injection
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 20 Jan 2010.
- Derived from this study: PubMed 20482446Tofoli GR, Cereda CM, Groppo FC, Volpato MC, Franz-Montan M, Ranali J, de Araujo DR, de Paula E. Efficacy of liposome-encapsulated mepivacaine for infiltrative anesthesia in volunteers. J Liposome Res. 2011 Mar;21(1):88-94. doi: 10.3109/08982104.2010.483596. Epub 2010 May 20.
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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.
Eneida de Paula, PHD study director
University of Campinas, Brazil
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 mepivacaine in people with Local Anesthetic Effectiveness, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 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 20 Jan 2010. 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 Brazil. 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?
Latency period and duration of anesthesia were assessed by an electrical pulp tester (time frame: 10 minutes). 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 NCT01032798, 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 20 Jan 2010.