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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904202
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Postherpetic Neuralgia
Diabetic Neuropathy
Complex Regional Pain Syndrome
Carpal Tunnel Syndrome
HIV Neuropathy
Idiopathic Sensory Neuropathy
Peripheral Neuropathy
Drug: 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
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Quality Assessment Scale (PQAS) [ Designated as safety issue: Yes ]
  • Investigator and Patient Global Impression of Change [ Designated as safety issue: No ]
  • Allodynia Testing [ Designated as safety issue: No ]
  • QoL; Symptom Checklist, pain interference with QoL [ Designated as safety issue: No ]
  • Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8) [ Designated as safety issue: No ]
  • Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: January 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Drug: Placebo Capsules + Placebo Patch
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 Name: Lidocaine patch 5%
Experimental: placebo capsules + Lidoderm patch (Lidocaine Group)
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
Drug: Placebo capsules + Lidoderm®
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 Name: Lidocaine patch 5%
Active Comparator: Gabapentin 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
Drug: Gabapentin + Placebo
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 Name: Lidocaine patch 5%
Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch
Gabapentin 300 mg capsules 1800 mg/day + placebo patch
Gabapentin capsules 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
Drug: Gabapentin + Lidoderm®
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 Name: Lidocaine patch 5%
Drug: Gabapentin 1800 mg/day + Lidoderm patch

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904202

Locations
United States, Alabama
Birmingham, Alabama, United States
Hueytown, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Florida
Pembroke Pines, Florida, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr Director, Clinical R&D, Endo Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00904202     History of Changes
Other Study ID Numbers: EN3220-009
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Complex Regional Pain Syndromes
Median Neuropathy
Mononeuropathies
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Signs and Symptoms
Poisoning
Substance-Related Disorders
Autonomic Nervous System Diseases
Lidocaine
Gabapentin
Gamma-Aminobutyric Acid
Anesthetics, Local

ClinicalTrials.gov processed this record on July 26, 2014