A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathy; Postherpetic Neuralgia; Low Back Pain

Treatments: Drug: Lidoderm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904020

EN3220-008

Details and patient eligibility

About

Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Were currently receiving an analgesic regimen that contained gabapentin
• Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
• Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
• For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)

Exclusion criteria

• Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
• Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
• Had received trigger point injections within 14 days 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

(1) Lidoderm

Experimental group

Description:

(1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.

Treatment:

Drug: Lidoderm