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

Phase 4

Completed

• Conditions: Diabetic Neuropathy; Complex Regional Pain Syndrome; Postherpetic Neuralgia; Idiopathic Sensory Neuropathy; Carpal Tunnel Syndrome; HIV Neuropathy; Peripheral Neuropathy
• Interventions: Drug: Gabapentin + Placebo; Drug: Gabapentin + Lidoderm®; Drug: Placebo Capsules + Placebo Patch; Drug: Placebo capsules + Lidoderm®; Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch; Drug: Gabapentin 1800 mg/day + Lidoderm patch

• Registration Number: NCT00904202
• Lead Sponsor: Endo Pharmaceuticals

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-06
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin capsules 1800 mg/day + placebo patch	Gabapentin + Placebo	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
Gabapentin capsules 1800 mg/day + Lidoderm patch	Gabapentin + Lidoderm®	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
placebo capsules + placebo patch	Placebo Capsules + Placebo Patch	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
Gabapentin capsules 1800 mg/day + placebo patch	Gabapentin 300 mg capsules 1800 mg/day + placebo patch	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
placebo capsules + Lidoderm patch (Lidocaine Group)	Placebo capsules + Lidoderm®	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
Gabapentin capsules 1800 mg/day + Lidoderm patch	Gabapentin 1800 mg/day + Lidoderm patch	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

Primary Outcome Measures

Name	Time	Method
Average daily pain intensity (BPI Questions 3,4,5, and 6)	Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)

Secondary Outcome Measures

Name	Time	Method
Investigator and Patient Global Impression of Change
Pain Quality Assessment Scale (PQAS)
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
Allodynia Testing
QoL; Symptom Checklist, pain interference with QoL