Patellar TendinopathyPhase 2NCT01111773
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
A Phase 2 study testing Heated Lidocaine and Tetracaine Patch in people with Patellar Tendinopathy, 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 and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Heated Lidocaine and Tetracaine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2011
- 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
- be at least 18 years of age
- have pain associated with patellar tendinopathy in a single knee (minimum 2-week duration)
- have tenderness at the proximal insertion of the patellar tendon in the affected knee
Who cannot join
- have any history of surgery in the target knee
- have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
- have had any injected steroids in the target knee within 3 months of 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.)
- 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 Patellar Tendinopathy
The purpose of the 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 patellar tendinopathy.
Read the detailed description
The purpose of this 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 patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.
- Conditions
- Patellar Tendinopathy
- Being tested
- Heated Lidocaine and Tetracaine Patch
- Keywords
- Patellar tendonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Lidocaine and Tetracaine PatchDrug
Also called Synera
Patients will apply one lidocaine 70 mg and tetracaine 70 mg topical patch to the affected knee twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours).
| Study group | Role | What they receive |
|---|---|---|
| Heated Lidocaine and Tetracaine Patch | Experimental | Not described Receives: Drug: Heated Lidocaine and Tetracaine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment (VISA) score
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
Measured: Two weeks
Secondary outcomes (2)
Pain intensity
Measured: Two weeks
Patient Global Assessment of Treatment Satisfaction (PGAS)
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 posted28 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Goitz, MD, Principal investigator, Detroit Medical Center, Sports Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111773
- Sponsor's protocol ID
- SC-204
- Status last verified
- Mar 2012
- First submitted
- 26 Apr 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 Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT01111773
- Acronym / sponsor ID
- SC-204
- Conditions
- Patellar Tendinopathy
- Keywords
- Patellar tendonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Apr 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 and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.
Detailed description
The purpose of this 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 patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.
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 and Tetracaine Patch | Experimental | Drug: Heated Lidocaine and Tetracaine Patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be at least 18 years of age
- have pain associated with patellar tendinopathy in a single knee (minimum 2-week duration)
- have tenderness at the proximal insertion of the patellar tendon in the affected knee
Key exclusion criteria (6 listed)
- have any history of surgery in the target knee
- have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
- have had any injected steroids in the target knee within 3 months of 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.)
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 PatchAlso: SyneraPatients will apply one lidocaine 70 mg and tetracaine 70 mg topical patch to the affected knee twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours). | Drug | Heated Lidocaine and Tetracaine Patch |
Primary outcome
Victorian Institute of Sport Assessment (VISA) score
Time frame: Two weeks
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
2 secondary outcomes
Pain intensity
Time frame: Two weeks
Patient Global Assessment of Treatment Satisfaction (PGAS)
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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Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT
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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.
Henry Goitz, MD principal investigator
Detroit Medical Center, Sports Medicine Clinic
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 Patch in people with Patellar Tendinopathy, 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 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?
Victorian Institute of Sport Assessment (VISA) score (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.