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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00904540
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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:
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
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
All locations for NCT00904540
United States (7)
Phoenix, Arizona, United States
Mill Valley, California, United States
Weston, Florida, United States
Bethpage, New York, United States
Charlotte, North Carolina, United States
Allentown, Pennsylvania, United States
Madison, Wisconsin, United States
View full eligibility
Tris trial is registered with FDA with number: NCT00904540. The sponsor of the trial is Endo Pharmaceuticals and it is looking for 131 volunteers for the current phase.
Official trial title: Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
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