Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Endo Pharmaceuticals
Treatments:
Lidocaine
Criteria
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)