Local AnesthesiaPhase 2NCT00889642
Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers
A Phase 2 study testing Iontophoretic Drug Delivery System with Lidocaine/Epinephrine and Iontophoretic Drug Delivery System with Epinephrine in people with Local Anesthesia, run by Dharma Therapeutics Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Iontophoretic Drug Delivery System with Lidocaine/Epinephrine and Iontophoretic Drug Delivery System with Epinephrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Jun 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of any race, either sex, and must be >18 years of age
- Healthy subjects as per medical screening
- Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
- Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
- Subjects must have signed and dated a written informed consent
- Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment
Who cannot join
- Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
- Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
- Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
- Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
- Subjects with an open skin lesion at the treatment site
- Subjects who are pregnant or breastfeeding
Show all 12Show fewer
- Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials
- Subjects who participated in previous DTI/Transcu clinical studies related to this product
- Subjects with known concurrent illness
- Subjects with "current" known/admitted substance abuse (alcohol/drug)
- Subjects with pacemakers and/or externally mounted electronic devices
- Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Vince & Associates Clinical Research
Overland Park, Missouri, 66212
About this study
Official title: A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesia for Venipuncture in Healthy Adult Volunteer Subjects
The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.
- Conditions
- Local Anesthesia
- Being tested
- Iontophoretic Drug Delivery System with Lidocaine/Epinephrine, Iontophoretic Drug Delivery System with Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoretic Drug Delivery System with Lidocaine/EpinephrineDevice
Active- 10.5% Lidocaine/0.179% Epinephrine
Iontophoretic Drug Delivery System with EpinephrineDevice
Placebo- 0.179% Epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Contains Lidocaine and Epinephrine Receives: Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine |
| Placebo | Placebo comparator | Contains Epinephrine Receives: Device: Iontophoretic Drug Delivery System with Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS).
Measured: 4 hours
Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment.
Measured: 4 hours
Secondary outcomes (1)
Determining the duration of anesthesia through standard pin prick testing.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dharma Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889642
- Sponsor's protocol ID
- Dharma-NSCO3
- Status last verified
- Jun 2009
- First submitted
- 27 Apr 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesia for Venipuncture in Healthy Adult Volunteer Subjects
- ClinicalTrials.gov ID
- NCT00889642
- Acronym / sponsor ID
- Dharma-NSCO3
- Conditions
- Local Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dharma Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Apr 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.
The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Iontophoretic Drug Delivery System with Lidocaine/EpinephrineContains Lidocaine and Epinephrine |
| Placebo | Placebo comparator | Device: Iontophoretic Drug Delivery System with EpinephrineContains Epinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects may be of any race, either sex, and must be >18 years of age
- Healthy subjects as per medical screening
- Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
- Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
- Subjects must have signed and dated a written informed consent
Key exclusion criteria (12 listed)
- Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
- Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
- Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
- Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
- Subjects with an open skin lesion at the treatment site
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 |
|---|---|---|
| Iontophoretic Drug Delivery System with Lidocaine/EpinephrineActive- 10.5% Lidocaine/0.179% Epinephrine | Device | Active |
| Iontophoretic Drug Delivery System with EpinephrinePlacebo- 0.179% Epinephrine | Device | Placebo |
Primary outcome
Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS).
Time frame: 4 hours
Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment.
Time frame: 4 hours
1 secondary outcome
Determining the duration of anesthesia through standard pin prick testing.
Time frame: 4 hours
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 23 Jun 2009.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iontophoretic Drug Delivery System with Lidocaine/Epinephrine and Iontophoretic Drug Delivery System with Epinephrine in people with Local Anesthesia, run by Dharma Therapeutics Inc. at 2 sites 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 6 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 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS). (time frame: 4 hours). The study lists 2 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 23 Jun 2009.