Status:
COMPLETED
Topical Lidocaine Patch in Low Back Pain
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Acute and Chronic Non-radicular LBP
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ac...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00904540
Start Date
March 1 2002
Last Update
January 2 2024
Active Locations (7)
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1
Phoenix, Arizona, United States
2
Mill Valley, California, United States
3
Weston, Florida, United States
4
Bethpage, New York, United States