Status:
COMPLETED
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Postherpetic Neuralgia
Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral ...
Eligibility Criteria
Inclusion
- Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
- Patients with PHN must have had pain \>3 months after rash healing
- Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
- Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
- Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
- Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
- Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
- Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
- Had never received an analgesic regimen that contained lidocaine or gabapentin
Exclusion
- Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
- Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00904202
Start Date
January 1 2003
Last Update
January 2 2024
Active Locations (7)
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1
Birmingham, Alabama, United States
2
Hueytown, Alabama, United States
3
Phoenix, Arizona, United States
4
Pembroke Pines, Florida, United States