A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
NCT ID: NCT00904111
Last Updated: 2013-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
215 participants
INTERVENTIONAL
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lidocaine 5% Patch
Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h)
Lidoderm®
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Placebo Topical Patch
Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)
Placebo Topical Patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Interventions
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Lidoderm®
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Placebo Topical Patch
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Endo Pharmaceuticals Inc.
Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Carlsbad, California, United States
National City, California, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Port Orange, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Pittsfield, Massachusetts, United States
Burlington, North Carolina, United States
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Cordova, Tennessee, United States
San Antonio, Texas, United States
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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EN3261-001
Identifier Type: -
Identifier Source: org_study_id