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

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Idiopathic Sensory Neuropathy; Diabetic Neuropathy; Postherpetic Neuralgia; Peripheral Neuropathy; HIV Neuropathy; Carpal Tunnel Syndrome; Complex Regional Pain Syndrome

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904202

EN3220-009

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 4 patient groups, including a placebo group

placebo capsules + placebo patch

Placebo Comparator group

Description:

Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing

Treatment:

Drug: Placebo Capsules + Placebo Patch

placebo capsules + Lidoderm patch (Lidocaine Group)

Experimental group

Description:

Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing

Treatment:

Drug: Placebo capsules + Lidoderm®

Gabapentin capsules 1800 mg/day + placebo patch

Active Comparator group

Description:

Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain

Treatment:

Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch

Drug: Gabapentin + Placebo

Gabapentin capsules 1800 mg/day + Lidoderm patch

Other group

Description:

Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain

Treatment:

Drug: Gabapentin + Lidoderm®

Drug: Gabapentin 1800 mg/day + Lidoderm patch