Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Chronic Low Back Pain

Treatments: Drug: Lidoderm®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904475

EN3220-011

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

1- Lidoderm®

Experimental group

Description:

Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Treatment:

Drug: Lidoderm®

Drug: Lidoderm®

2-Placebo

Placebo Comparator group

Description:

Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain

Treatment:

Drug: Lidoderm®

Drug: Lidoderm®