Back PainNCT02749123
Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
A study testing lidocaine 5% patch and lidocaine 3.6%, menthol 1.25% in people with Back Pain and Arthritis, run by J.A.R. Laboratories at 1 site in United States.
Trial summary
A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- lidocaine 5% patch and lidocaine 3.6%, menthol 1.25%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2016
- Phase
- Interventional
- 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
- Diagnosis of back pain
- Diagnosis of arthritis
Who cannot join
- Pregnancy or expected pregnancy in the next three months
- Allergic to any lidocaine, menthol and methylparaben
- No reliable access to the internet
- Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10.
- Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Advocate Good Sheppard Hospital
Barrington, Illinois, 60010
Eric Castro, MD, 773-771-4160, jedc269@yahoo.com
About this study
A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
Read the detailed description
In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.
- Being tested
- lidocaine 5% patch, lidocaine 3.6%, menthol 1.25%, Placebo
- Medical subject headings
- Back Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine 5% patchDrug
Also called Lidoderm
10cmx 14 cm transdermal patch sealed in its own pouch
lidocaine 3.6%, menthol 1.25%Drug
Also called LidoPatch
10cmx 14 cm transdermal patch sealed in its own pouch
PlaceboDrug
patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine5% v Lidocaine3.6%,Menthol1.25% | Active comparator | Daily patch Q12 followed by Q12 of no patch Receives: Drug: lidocaine 5% patch; Drug: lidocaine 3.6%, menthol 1.25% |
| Lidocaine 3.6%, menthol 1.25% v placebo | Placebo comparator | Daily patch Q12 followed by Q12 of no patch Receives: Drug: lidocaine 3.6%, menthol 1.25%; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten
Measured: Day ten
Secondary outcomes (4)
Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.
Measured: Day ten
Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.
Measured: Day 10
Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.
Measured: Day 10
Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J.A.R. Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749123
- Sponsor's protocol ID
- 527-03
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Investigators plan to share the study results as a whole but no plans to share individual results.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
- ClinicalTrials.gov ID
- NCT02749123
- Acronym / sponsor ID
- 527-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- J.A.R. LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 22 Apr 2016 (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.
A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
Detailed description
In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.
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 |
|---|---|---|
| Lidocaine5% v Lidocaine3.6%,Menthol1.25% | Active comparator | Drug: lidocaine 5% patch, Drug: lidocaine 3.6%, menthol 1.25%Daily patch Q12 followed by Q12 of no patch |
| Lidocaine 3.6%, menthol 1.25% v placebo | Placebo comparator | Drug: lidocaine 3.6%, menthol 1.25%, Drug: PlaceboDaily patch Q12 followed by Q12 of no 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)
- Diagnosis of back pain
- Diagnosis of arthritis
Key exclusion criteria (5 listed)
- Pregnancy or expected pregnancy in the next three months
- Allergic to any lidocaine, menthol and methylparaben
- No reliable access to the internet
- Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10.
- Pain on the area of the body not conducive to patch therapy (eg fingers, toes 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 |
|---|---|---|
| lidocaine 5% patchAlso: Lidoderm10cmx 14 cm transdermal patch sealed in its own pouch | Drug | Lidocaine5% v Lidocaine3.6%,Menthol1.25% |
| lidocaine 3.6%, menthol 1.25%Also: LidoPatch10cmx 14 cm transdermal patch sealed in its own pouch | Drug | Lidocaine 3.6%, menthol 1.25% v placebo, Lidocaine5% v Lidocaine3.6%,Menthol1.25% |
| Placebopatch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch | Drug | Lidocaine 3.6%, menthol 1.25% v placebo |
Primary outcome
Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Time frame: Day ten
Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten
4 secondary outcomes
Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Time frame: Day ten
Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Time frame: Day 10
Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Time frame: Day 10
Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
Time frame: Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: No. Investigators plan to share the study results as a whole but no plans to share individual results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine 5% patch and lidocaine 3.6%, menthol 1.25% in people with Back Pain and Arthritis, run by J.A.R. Laboratories 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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2016. 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James J Ciullo, MBA (6302512873, jay@lidopatch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale (time frame: Day ten). 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 22 Apr 2016.