Carpal Tunnel SyndromePhase 2NCT00991068
Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
A Phase 2 study testing Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch in people with Carpal Tunnel Syndrome, run by ZARS Pharma Inc. at 1 site in United States.
Trial summary
The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
- Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)
Who cannot join
- Have bilateral carpal tunnel syndrome
- Have another peripheral neuropathy in the affected limb
- Have had an injection into the carpal tunnel within 8 weeks
- Have had surgical release of the target wrist within previous 6 months
- Have electrodiagnostic evidence of severe CTS
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
International Clinical Research Institute
Overland Park, Kansas, 66211
About this study
Official title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.
Read the detailed description
ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch
- Keywords
- Pain, Mild to moderate Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synera (lidocaine 70 mg and tetracaine 70 mg) topical patchDrug
Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Synera | Experimental | Synera topical patch Receives: Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Secondary outcomes (1)
Pain interference with activities (general, normal work, sleep)
Measured: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srinivas Nalamachu, MD, Principal investigator, International Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991068
- Sponsor's protocol ID
- SC-201
- Status last verified
- Mar 2012
- First submitted
- 6 Oct 2009
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT00991068
- Acronym / sponsor ID
- SC-201
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Pain, Mild to moderate Carpal Tunnel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Oct 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 the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.
Detailed description
ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synera | Experimental | Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patchSynera topical patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
- Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)
Key exclusion criteria (6 listed)
- Have bilateral carpal tunnel syndrome
- Have another peripheral neuropathy in the affected limb
- Have had an injection into the carpal tunnel within 8 weeks
- Have had surgical release of the target wrist within previous 6 months
- Have electrodiagnostic evidence of severe CTS
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 |
|---|---|---|
| Synera (lidocaine 70 mg and tetracaine 70 mg) topical patchPatients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days. | Drug | Synera |
Primary outcome
Pain intensity
Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
1 secondary outcome
Pain interference with activities (general, normal work, sleep)
Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
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 16 Mar 2012.
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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.
Srinivas Nalamachu, MD principal investigator
International Clinical Research 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 Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch in people with Carpal Tunnel Syndrome, run by ZARS Pharma 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 2 inclusion and 6 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 16 Mar 2012. 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?
Pain intensity (time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal). 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 16 Mar 2012.