Chronic Low Back PainPhase 2NCT00904111
A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
A Phase 2 study testing Lidoderm® in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 18 sites in United States.
Trial summary
Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lidoderm®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2004to Oct 2005
- 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
- Had axial LBP with or without radiation present for at least 3 months as defined as:
- Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below
- Chronic axial LBP with radiation: pain that radiates to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50%
- Had daily moderate to severe LBP as the primary source of pain
- Had a normal neurological examination, including:
- Motor strength
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- Sensory exam in lower extremities
- Deep tendon reflexes
- Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).
- Had a daily average pain intensity rating of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as "no pain" and 10 was defined as "pain as bad as ever imagined" as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary
Who cannot join
- Had spinal stenosis with > 50% leg pain component
- Had elective surgery scheduled to occur during the 14-week study
- Had a history of one or more back surgeries within 1 year of study entry
- Had severe renal insufficiency (creatinine clearance of <30mL/min)
- Had moderate or greater hepatic impairment
- Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
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- Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period
- Had received an epidural steroid/local anesthesia injection within 4 weeks prior to study entry
- Had received trigger point injections within 2 weeks prior to study entry
- Had received Botulinum Toxin (Botox) Injections for LBP within 6 months prior to study entry
- Were using a lidocaine-containing product that could not be discontinued during the study
- Were using any topical medication applied to the low back region
- Had previously failed treatment with Lidoderm analgesic patch for LBP
- Were taking class 1 anti-arrhythmic drugs (e.g. mexiletine, tocainide)
- Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Altoona, Pennsylvania
Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Burlington, North Carolina
Study site
Carlsbad, California
Study site
Chicago, Illinois
Study site
Cordova, Tennessee
Study site
Duncansville, Pennsylvania
Study site
National City, California
Study site
Overland Park, Kansas
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsfield, Massachusetts
Study site
Port Orange, Florida
Study site
San Antonio, Texas
Study site
Virginia Beach, Virginia
Study site
Washington D.C., District of Columbia
Study site
Waterbury, Connecticut
About this study
Official title: A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lidoderm®, Placebo Topical Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidoderm®Drug
Also called Lidocaine 5% Patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Placebo Topical PatchDrug
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 5% Patch | Experimental | Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h) Receives: Drug: Lidoderm® |
| Placebo Topical Patch | Placebo comparator | Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h) Receives: Drug: Placebo Topical Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Question 5 of the BPI)
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
Secondary outcomes (1)
Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration
Measured: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
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 startAug 2004
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 215 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
- NCT00904111
- Sponsor's protocol ID
- EN3261-001
- Status last verified
- Feb 2010
- First submitted
- 15 May 2009
- Last updated
- 6 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
- ClinicalTrials.gov ID
- NCT00904111
- Acronym / sponsor ID
- EN3261-001
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Oct 2005 (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 Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 5% Patch | Experimental | Drug: Lidoderm®Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h) |
| Placebo Topical Patch | Placebo comparator | Drug: Placebo Topical PatchMatching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Had axial LBP with or without radiation present for at least 3 months as defined as:
- Had daily moderate to severe LBP as the primary source of pain
- Had a normal neurological examination, including:
- Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).
Key exclusion criteria (15 listed)
- Had spinal stenosis with > 50% leg pain component
- Had elective surgery scheduled to occur during the 14-week study
- Had a history of one or more back surgeries within 1 year of study entry
- Had severe renal insufficiency (creatinine clearance of <30mL/min)
- Had moderate or greater hepatic impairment
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 5% PatchEligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch. | Drug | Lidocaine 5% Patch |
| Placebo Topical PatchEligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch. | Drug | Placebo Topical Patch |
Primary outcome
Pain intensity (Question 5 of the BPI)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
1 secondary outcome
Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
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 6 Dec 2013.
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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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidoderm® in people with Chronic Low Back Pain, run by Endo USA Inc., a Keenova Therapeutics Company at 18 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 11 inclusion and 15 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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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.
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 (Question 5 of the BPI) (time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)). 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 6 Dec 2013.