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Topical Lidocaine Patch in Low Back Pain

CompletedPhase 4NCT00904540
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official title
Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain
Conditions
  • Acute and Chronic Non-radicular LBP
Interventions
Sponsor
Endo USA Inc., a Keenova Therapeutics Company
Start date
2002-03
Primary completion
2002-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
7

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00904540