Shoulder Impingement SyndromePhase 2NCT01055444
Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
A Phase 2 study testing Heated lidocaine and tetracaine topical patch in people with Shoulder Impingement 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 a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Heated lidocaine and tetracaine topical patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 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 shoulder impingement syndrome in a single shoulder
- Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
- Have positive Hawkins and Neers signs
Who cannot join
- Have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline visit
- Have used any injected pain medication within 14 days preceding the Screening/Baseline visit
- Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
- Have a history of and/or past diagnosis of severe hepatic disease
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome
Read the detailed description
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Heated lidocaine and tetracaine topical patch
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated lidocaine and tetracaine topical patchDrug
Also called Synera
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Heated lidocaine/tetracaine topical patch | Experimental | Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours. Receives: Drug: Heated lidocaine and tetracaine topical patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured: Two weeks
Secondary outcomes (1)
Pain interference with activities (general, normal work, and sleep)
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Radnovich, DO, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055444
- Sponsor's protocol ID
- SC-202
- Status last verified
- Mar 2012
- First submitted
- 21 Jan 2010
- 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 Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01055444
- Acronym / sponsor ID
- SC-202
- Conditions
- Shoulder Impingement Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Jan 2010 (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 a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome
Detailed description
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heated lidocaine/tetracaine topical patch | Experimental | Drug: Heated lidocaine and tetracaine topical patchPatients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain associated with shoulder impingement syndrome in a single shoulder
- Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
- Have positive Hawkins and Neers signs
Key exclusion criteria (5 listed)
- Have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline visit
- Have used any injected pain medication within 14 days preceding the Screening/Baseline visit
- Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
- Have a history of and/or past diagnosis of severe hepatic disease
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Heated lidocaine and tetracaine topical patchAlso: SyneraPatients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours. | Drug | Heated lidocaine/tetracaine topical patch |
Primary outcome
Pain intensity
Time frame: Two weeks
1 secondary outcome
Pain interference with activities (general, normal work, and sleep)
Time frame: Two weeks
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.
Richard Radnovich, DO principal investigator
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 Heated lidocaine and tetracaine topical patch in people with Shoulder Impingement 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 3 inclusion and 5 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: Two weeks). 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.