AnesthesiaPhase 1NCT01425840
Liposomal Lidocaine Gel for Oral Topical Anesthesia
A Phase 1 study testing Lidocaine in people with Anesthesia, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Mar 2009
- 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 35 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 of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.
Read the detailed description
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.
- Conditions
- Anesthesia
- Being tested
- Lidocaine
- Keywords
- Lidocaine,, liposome encapsulation,, topical anesthesia,, palatal mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Topical anesthesia in the palatal mucosa
100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal lidocaine, topical anesthesia | Experimental | Efficacy of Liposomal lidocaine in topical anesthesia. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of topical anesthetics on the oral mucosa.
The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionMar 2009
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 AnesthesiaStudies 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
- 40 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425840
- Sponsor's protocol ID
- 112/2007
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.
PubMed 21106282
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Liposome Lidocaine Gel for Topical Anesthesia in the Palatal Mucosa
- ClinicalTrials.gov ID
- NCT01425840
- Acronym / sponsor ID
- 112/2007
- Conditions
- Anesthesia
- Keywords
- Lidocaine,, liposome encapsulation,, topical anesthesia,, palatal mucosa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Aug 2011 (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 aimed to evaluate the efficacy of topical liposome-encapsulated lidocaine on oral mucosa.
Detailed description
This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated 2,5 and 5% lidocaine gel formulations on the palatal mucosa.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal lidocaine, topical anesthesia | Experimental | Drug: LidocaineEfficacy of Liposomal lidocaine in topical anesthesia. |
Who may qualify
- Ages
- 18 to 35 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 |
|---|---|---|
| LidocaineAlso: Topical anesthesia in the palatal mucosa100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes. | Drug | Liposomal lidocaine, topical anesthesia |
Primary outcome
The efficacy of topical anesthetics on the oral mucosa.
Time frame: 10 seconds
The topical formulations were kept in the palatal mucosa during 2 min. The efficacy of the topical formulations was assessed after a pinprick and a local anesthetic injection on the application site.
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 30 Aug 2011.
- Results publication: PubMed 21106282Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lidocaine in people with Anesthesia, 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 30 Aug 2011. 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?
The efficacy of topical anesthetics on the oral mucosa. (time frame: 10 seconds). 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 NCT01425840, 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 30 Aug 2011.