Soft Tissue Anesthesia (Numbness)Phase 2NCT00154167
Safety and Efficacy Study of NV-101 in Dental Patients
A Phase 2 study testing NV-101 (phentolamine mesylate solution) in people with Soft Tissue Anesthesia (Numbness), run by Novalar Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study was: to determine if NV-101 accelerates recovery from numbness compared to placebo to evaluate safety of NV-101 Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Anesthesia (Numbness)
- What is being tested?
- NV-101 (phentolamine mesylate solution)
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jun 2003
- 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 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Between 10-65 years of age
- Body weight between 35 to 110 kg
- Healthy as determined by the Investigator based on medical history, physical examination, and 12 Lead ECG
- Clinical laboratory tests within the reference ranges or within clinically acceptable limits according to the Investigator
- Normal lip, nose, chin, and tongue sensations
- Women of childbearing potential must have agreed to use barrier contraception for the duration of the study (Women of childbearing potential included all women except for those who are premenstrual, whose menstrual periods have not occured for greater than or equal to one year after menopause, who are surgically sterilized, or who have had a hysterectomy)
- Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol
Who cannot join
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue disease or disorder
- Clinically relevant surgical history
- History of alcoholism and/or drug abuse within the past 5 years
- Significant infection or known inflammatory process including viral infections
- Required prophylactic antibiotics for SBE (infectious endocarditis)
- Had acute gastrointestinal symptoms at screening and/or baseline
Show all 12Show fewer
- Allergies to any of the following: lidocaine/epinephrine, articaine/epinephrine, prilocaine/epinephrine, bisulfites or metasulfites, or phentolamine
- Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
- Used pain relievers 24 hours prior to anesthetic administration
- Required the use of nitrous oxide or sedatives to perform the scheduled, eligible dental procedure
- Pregnancy, attempting to conceive,or lactating
- Used decongestants or other drugs with vasoactive moieties within 24 hours prior to anesthetic administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients
The purpose of this study was:
- to determine if NV-101 accelerates recovery from numbness compared to placebo
- to evaluate safety of NV-101
Read the detailed description
This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. The investigators were licensed dentists in private practice. Each patient received one or more conventional injections of either articaine with epinephrine, lidocaine with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed within 4mm of each other constituted the same site. The injection(s) of study drug were made at or near the completion of the dental procedure and were required to be not earlier than 20 minutes after, and not later than 70 minutes after, the most recent injection of local anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local anesthetic had been injected (i.e. no more than 2 sites).
Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.
Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.
- Conditions
- Soft Tissue Anesthesia (Numbness)
- Being tested
- NV-101 (phentolamine mesylate solution)
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NV-101 (phentolamine mesylate solution)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Anesthesia (Numbness)Studies 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
- Double blind
- Enrolment
- 122 participants
Sponsor and investigators
- Lead sponsor
- Novalar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Royce Morrison, MD, Principal investigator, Northwest Kinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154167
- Sponsor's protocol ID
- NOVA 03-001
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of NV-101 in Dental Patients
- ClinicalTrials.gov ID
- NCT00154167
- Acronym / sponsor ID
- NOVA 03-001
- Conditions
- Soft Tissue Anesthesia (Numbness)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants
- Lead sponsor
- Novalar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Jun 2003
- First posted
- 12 Sep 2005 (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 was:
- to determine if NV-101 accelerates recovery from numbness compared to placebo
- to evaluate safety of NV-101
Detailed description
This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. The investigators were licensed dentists in private practice. Each patient received one or more conventional injections of either articaine with epinephrine, lidocaine with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed within 4mm of each other constituted the same site. The injection(s) of study drug were made at or near the completion of the dental procedure and were required to be not earlier than 20 minutes after, and not later than 70 minutes after, the most recent injection of local anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local anesthetic had been injected (i.e. no more than 2 sites).
Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by palpations at 5-minute intervals beginning 1 minute before the study drug injection and continuing for a minimum of 3 hours and until they achieved the return of normal sensation in lip, tongue, nose, and chin.
Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical examinations including oral cavity examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Between 10-65 years of age
- Body weight between 35 to 110 kg
- Healthy as determined by the Investigator based on medical history, physical examination, and 12 Lead ECG
- Clinical laboratory tests within the reference ranges or within clinically acceptable limits according to the Investigator
- Normal lip, nose, chin, and tongue sensations
Key exclusion criteria (12 listed)
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue disease or disorder
- Clinically relevant surgical history
- History of alcoholism and/or drug abuse within the past 5 years
- Significant infection or known inflammatory process including viral infections
- Required prophylactic antibiotics for SBE (infectious endocarditis)
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 |
|---|---|---|
| NV-101 (phentolamine mesylate solution) | Drug | – |
Primary outcome
Not reported in the source record.
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 14 Sep 2005.
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.
Royce Morrison, MD principal investigator
Northwest Kinetics
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 NV-101 (phentolamine mesylate solution) in people with Soft Tissue Anesthesia (Numbness), 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 7 inclusion and 12 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 14 Sep 2005. 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.
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 14 Sep 2005.