Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
CompletedPhase 4NCT00904475
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 moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.
Study details
- Official title
- A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
- Conditions
- Interventions
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Start date
- 2003-04
- Primary completion
- 2003-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Were currently experiencing moderate/severe pain despite current analgesic treatment 2. Had daily moderate-to-severe LBP for at least 3 months duration 3. Had a mean daily pain intensity score of \>6 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) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week Exclusion Criteria: 1. Had a history of greater than one back surgery, or one back surgery within 3 months of study entry 2. Had severe spinal stenosis 3. Had chronic back pain of \>12 months duration with an undefined spinal diagnosis 4. Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.) 5. Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry 6. Had received trigger point injections within 2 weeks prior to study entry 7. Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry 8. Were taking a lidocaine-containing product that could not be discontinued while receiving study medication 9. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) 10. Had received Lidoderm for LBP in the past
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00904475