Anesthesia, DentalPhase 2NCT00309322
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
A Phase 2 study testing Phentolamine Mesylate (NV-101) in people with Anesthesia, Dental, run by Novalar Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Anesthesia, Dental
- What is being tested?
- Phentolamine Mesylate (NV-101)
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2006
- Phase
- Phase 2
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, 4 to 11 years of age
- Sufficiently healthy, as determined by the Investigator, to receive routine dental care
- Requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth
- Requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection
- Dental procedure(s) completed with 60 minutes of injection of local anesthetic
- Can be trained to complete the Wong Baker Pain Rating Scale
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- For subjects 6 to 11 years of age who are trainable in standardized palpation procedure:
- have normal lip sensation at baseline prior to administration of local anesthetic
- have numbness of the relevant lip quadrant at completion of the dental procedure
- Negative urine pregnancy test at screening in female subjects who are past menarche
- Subjects give written or verbal assent, as applicable, and parents(s) or legal guardian(s) give written informed consent
Who cannot join
- Weight less than 15 kg
- History or presence of any condition that contraindicates routine dental care or use of local anesthetic
- Requires more than half cartridge of local anesthetic if weight is greater than or equal to 15 kg and less than 30 kg and more than one cartridge of local anesthetic if weight is greater than or equal to 30 kg, excluding supplemental injections
- Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, or topical benzocaine
- Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
- Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
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- Use of opioid-like analgesics within 24 hours prior to administration of local anesthetic
- Requires the use of local anesthetic other than lidocaine/epinephrine to perform the scheduled dental procedure
- Requires the use of nitrous oxide or sedatives to perform the scheduled dental procedure
- Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in the study or decreases the likelihood of compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.
- Conditions
- Anesthesia, Dental
- Being tested
- Phentolamine Mesylate (NV-101)
- Keywords
- Soft Tissue Anesthesia (Numbness)
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Mesylate (NV-101)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
(All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse events
incidence, severity and duration of intraoral pain as measured by Wong Baker Pain Rating Scale
clinically significant changes in vital signs
clinically significant changes in oral cavity assessments
analgesics required for intraoral pain
Secondary outcomes (2)
(For subjects 6 to 11 years of age who are trainable in standardized palpation procedure): to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
for mandibular procedures, to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startMar 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, DentalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Novalar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary Tavares, DDS, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309322
- Sponsor's protocol ID
- NOVA 05-PEDS
- Status last verified
- Nov 2006
- First submitted
- 30 Mar 2006
- Last updated
- 17 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
- ClinicalTrials.gov ID
- NCT00309322
- Acronym / sponsor ID
- NOVA 05-PEDS
- Conditions
- Anesthesia, Dental
- Keywords
- Soft Tissue Anesthesia (Numbness)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Novalar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2006
- First posted
- 31 Mar 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.
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Male or female, 4 to 11 years of age
- Sufficiently healthy, as determined by the Investigator, to receive routine dental care
- Requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth
- Requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection
- Dental procedure(s) completed with 60 minutes of injection of local anesthetic
Key exclusion criteria (10 listed)
- Weight less than 15 kg
- History or presence of any condition that contraindicates routine dental care or use of local anesthetic
- Requires more than half cartridge of local anesthetic if weight is greater than or equal to 15 kg and less than 30 kg and more than one cartridge of local anesthetic if weight is greater than or equal to 30 kg, excluding supplemental injections
- Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, or topical benzocaine
- Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
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 |
|---|---|---|
| Phentolamine Mesylate (NV-101) | Drug | – |
Primary outcome
(All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse events
incidence, severity and duration of intraoral pain as measured by Wong Baker Pain Rating Scale
clinically significant changes in vital signs
clinically significant changes in oral cavity assessments
analgesics required for intraoral pain
2 secondary outcomes
(For subjects 6 to 11 years of age who are trainable in standardized palpation procedure): to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
for mandibular procedures, to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
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 17 Nov 2006.
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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.
Mary Tavares, DDS principal investigator
The Forsyth Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phentolamine Mesylate (NV-101) in people with Anesthesia, Dental, run by Novalar Pharmaceuticals, Inc. at 1 site in United States.
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 11 inclusion and 10 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 17 Nov 2006. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
(All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse events. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2006.