Last updated: December 29, 2023
Sponsor: Endo Pharmaceuticals
Overall Status: Completed
Phase
4
Condition
Diabetic Neuropathy
Postherpetic Neuralgia
Carpal Tunnel Syndrome
Treatment
Gabapentin 1800 mg/day + Lidoderm patch
Gabapentin + Placebo
Gabapentin + Lidoderm®
Clinical Study ID
NCT00904202
EN3220-009
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathicsensory neuropathy, or other peripheral neuropathy (upon mutual agreement of thesponsor 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 symmetricsensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
- Patients with CRPS must have met current IASP (International Association for the Studyof Pain) diagnostic criteria
- Patients with carpal tunnel syndrome must have had a diagnosis by combination clinicalneurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostictesting, and daily painful symptoms of at least 3 months' duration
- Patients with HIV neuropathy must have had HIV, subjective symptoms of painfulperipheral 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 greaterthan 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
Exclusion Criteria:
- Had a neurological condition other than that associated with their pain diagnosiswhich, in the opinion of the investigator, would interfere with their ability toparticipate in the study
- Were taking a lidocaine-containing product that could not be discontinued whilereceiving lidocaine
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Study Design
Total Participants: 62
Treatment Group(s): 6
Primary Treatment: Gabapentin 1800 mg/day + Lidoderm patch
Phase: 4
Study Start date:
January 01, 2003
Estimated Completion Date:
Connect with a study center
Birmingham, Alabama
United StatesSite Not Available
Hueytown, Alabama
United StatesSite Not Available
Phoenix, Arizona
United StatesSite Not Available
Pembroke Pines, Florida
United StatesSite Not Available
New York, New York
United StatesSite Not Available
Rochester, New York
United StatesSite Not Available
Altoona, Pennsylvania
United StatesSite Not Available
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