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

May 15, 2009
February 12, 2010
January 2003
June 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00904202 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Postherpetic Neuralgia
  • Diabetic Neuropathy
  • Complex Regional Pain Syndrome
  • Carpal Tunnel Syndrome
  • HIV Neuropathy
  • Idiopathic Sensory Neuropathy
  • Peripheral Neuropathy
  • 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%
  • 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%
  • 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 + 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 300 mg capsules 1800 mg/day + placebo patch
    Gabapentin 300 mg capsules 1800 mg/day + placebo patch
  • Drug: Gabapentin 1800 mg/day + Lidoderm patch
  • 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
    Intervention: Drug: Placebo Capsules + Placebo Patch
  • 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
    Intervention: Drug: Placebo capsules + Lidoderm®
  • 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
    Interventions:
    • Drug: Gabapentin + Placebo
    • Drug: 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
    Interventions:
    • Drug: Gabapentin + Lidoderm®
    • Drug: Gabapentin 1800 mg/day + Lidoderm patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
Not Provided
June 2003   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00904202
EN3220-009
No
Sr Director, Clinical R&D, Endo Pharmaceuticals Inc
Endo Pharmaceuticals
Not Provided
Study Director: Sr Director Endo Pharmaceuticals
Endo Pharmaceuticals
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP