Acute and Chronic Non-radicular LBPPhase 4NCT00904540
Topical Lidocaine Patch in Low Back Pain
A Phase 4 study testing Lidoderm® in people with Acute and Chronic Non-radicular LBP, run by Endo USA Inc., a Keenova Therapeutics Company at 7 sites in United States.
Trial summary
Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute and Chronic Non-radicular LBP
- What is being tested?
- Lidoderm®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2002to Oct 2002
- Phase
- Phase 4
- 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
- Non-radicular LBP pain for
- ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg)
- Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms
- Had an average daily pain intensity score of >4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit.
- Had a normal neurological examination, including:
- Motor strength
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- Sensory testing (light touch, pinprick, and vibration)
- Deep tendon reflexes
- Patients were eligible for participation in the long-term chronic (>12 months) group of the study if they also:
- Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy
Who cannot join
- Had a history of greater than one back surgery or one back surgery within 3 months of study entry
- Had severe spinal stenosis and radicular symptoms
- Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
- Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
- Had received Botox Injections within 3 months prior to study entry
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- Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
- Patients were excluded from participation in the long-term chronic (>12 months) group if they also:
- Had an undefined spinal diagnosis
- Had a history of lumbar spine surgery within 6 months prior to study entry
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Allentown, Pennsylvania
Study site
Bethpage, New York
Study site
Charlotte, North Carolina
Study site
Madison, Wisconsin
Study site
Mill Valley, California
Study site
Phoenix, Arizona
Study site
Weston, Florida
About this study
Official title: Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.
- Conditions
- Acute and Chronic Non-radicular LBP
- Being tested
- Lidoderm®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidoderm®Drug
Also called Lidocaine patch 5%
Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP)
| Study group | Role | What they receive |
|---|---|---|
| Lidoderm® | Experimental | Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain Receives: Drug: Lidoderm® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2
Measured: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Secondary outcomes (4)
Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI)
Measured: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores
Measured: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief
Measured: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments.
Measured: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMar 2002
- Primary completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic Non-radicular LBPStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904540
- Sponsor's protocol ID
- EN3220-006
- Status last verified
- Dec 2023
- First submitted
- 15 May 2009
- Last updated
- 2 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
- ClinicalTrials.gov ID
- NCT00904540
- Acronym / sponsor ID
- EN3220-006
- Conditions
- Acute and Chronic Non-radicular LBP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2002 (actual)
- First posted
- 19 May 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.
Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidoderm® | Experimental | Drug: Lidoderm®Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-radicular LBP pain for
- ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg)
- Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms
- Had an average daily pain intensity score of >4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit.
- Had a normal neurological examination, including:
Key exclusion criteria (11 listed)
- Had a history of greater than one back surgery or one back surgery within 3 months of study entry
- Had severe spinal stenosis and radicular symptoms
- Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
- Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
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 |
|---|---|---|
| Lidoderm®Also: Lidocaine patch 5%Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP) | Drug | Lidoderm® |
Primary outcome
Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
4 secondary outcomes
Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments.
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)
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 2 Jan 2024.
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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidoderm® in people with Acute and Chronic Non-radicular LBP, run by Endo USA Inc., a Keenova Therapeutics Company at 7 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 10 inclusion and 11 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 (time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)). 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 2 Jan 2024.