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Completed

NCT Number: NCT00904202

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

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.

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Key information

Conditions

Postherpetic Neuralgia Autonomic Nervous System Diseases Carpal Tunnel Syndrome Complex Regional Pain Syndrome Complex Regional Pain Syndromes Cumulative Trauma Disorders Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases HIV Neuropathy Idiopathic Sensory Neuropathy Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathy Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Placebo Capsules + Placebo Patch

Drug

Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).

Other names: Lidocaine patch 5%

Placebo capsules + Lidoderm®

Drug

Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).

Other names: Lidocaine patch 5%

Gabapentin + Placebo

Drug

Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).

Other names: Lidocaine patch 5%

Gabapentin + Lidoderm®

Drug

Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).

Other names: Lidocaine patch 5%

Gabapentin 300 mg capsules 1800 mg/day + placebo patch

Drug

Gabapentin 300 mg capsules 1800 mg/day + placebo patch

Gabapentin 1800 mg/day + Lidoderm patch

Drug

Primary outcomes

  1. Average daily pain intensity (BPI Questions 3,4,5, and 6)

    Time frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)

Secondary outcomes

  1. Pain Quality Assessment Scale (PQAS)

  2. Investigator and Patient Global Impression of Change

  3. Allodynia Testing

  4. QoL; Symptom Checklist, pain interference with QoL

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

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

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
First posted
May 19, 2009
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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