We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904202
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2003
Actual Primary Completion Date : June 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904202


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Sr Director Endo Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sr Director, Clinical R&D, Endo Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00904202    
Other Study ID Numbers: EN3220-009
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuralgia
Carpal Tunnel Syndrome
Diabetic Neuropathies
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Neuralgia, Postherpetic
Syndrome
Disease
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Median Neuropathy
 Mononeuropathies
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Autonomic Nervous System Diseases
Lidocaine
Gabapentin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs