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

Condition(s) targeted: Postherpetic Neuralgia; Diabetic Neuropathy; Complex Regional Pain Syndrome; Carpal Tunnel Syndrome; HIV Neuropathy; Idiopathic Sensory Neuropathy; Peripheral Neuropathy

Intervention: Placebo Capsules + Placebo Patch (Drug); Placebo capsules + Lidoderm® (Drug); Gabapentin + Placebo (Drug); Gabapentin + Lidoderm® (Drug); Gabapentin 300 mg capsules 1800 mg/day + placebo patch (Drug); Gabapentin 1800 mg/day + Lidoderm patch (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Sr Director, Study Director, Affiliation: Endo Pharmaceuticals

Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Average daily pain intensity (BPI Questions 3,4,5, and 6)

Secondary outcome:

Pain Quality Assessment Scale (PQAS)

Investigator and Patient Global Impression of Change

Allodynia Testing

QoL; Symptom Checklist, pain interference with QoL

Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)

Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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) 2. Patients with PHN must have had pain >3 months after rash healing 3. 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 4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria 5. 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 6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration 7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration 8. 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) 9. Had never received an analgesic regimen that contained lidocaine or gabapentin Exclusion Criteria: 1. 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 2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine 3. Were taking class 1 anti-arrhythmic drugs (e. g., mexiletine, tocainide)

Birmingham, Alabama, United States

Hueytown, Alabama, United States

Phoenix, Arizona, United States

Pembroke Pines, Florida, United States

New York, New York, United States

Rochester, New York, United States

Altoona, Pennsylvania, United States

Starting date: January 2003
Last updated: February 12, 2010