Status:
COMPLETED
A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Postherpetic Neuralgia
Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00904020
Start Date
June 1 2002
Last Update
January 2 2024
Active Locations (11)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Plantation, Florida, United States
4
Marietta, Georgia, United States