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 | RxWiki

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

Overview[ - collapse ][ - ]

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	Postherpetic Neuralgia Diabetic Neuropathy Complex Regional Pain Syndrome Carpal Tunnel Syndrome HIV Neuropathy Idiopathic Sensory Neuropathy Peripheral Neuropathy
Intervention	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	Phase 4
Sponsor	Endo Pharmaceuticals
Responsible Party	Endo Pharmaceuticals
ClinicalTrials.gov Identifier	NCT00904202
First Received	May 15, 2009
Last Updated	February 12, 2010
Last verified	February 2010

Tracking Information[ + expand ][ + ]

First Received Date	May 15, 2009
Last Updated Date	February 12, 2010
Start Date	January 2003
Estimated Primary Completion Date	Not Provided
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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
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 Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Postherpetic Neuralgia Diabetic Neuropathy Complex Regional Pain Syndrome Carpal Tunnel Syndrome HIV Neuropathy Idiopathic Sensory Neuropathy Peripheral Neuropathy
Intervention	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 Names: 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 Names: 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 Names: 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 Names: 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
Study Arm (s)	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 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 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 Other: 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	62
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	June 2003
Eligibility 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)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00904202
Other Study ID Numbers	EN3220-009
Has Data Monitoring Committee	No
Information Provided By	Endo Pharmaceuticals
Study Sponsor	Endo Pharmaceuticals
Collaborators	Not Provided
Investigators	Study Director: Sr Director Endo Pharmaceuticals
Verification Date	February 2010

Locations[ + expand ][ + ]

United States, Alabama	Birmingham, Alabama, United States
United States, Alabama	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
United States, New York	Rochester, New York, United States
United States, Pennsylvania	Altoona, Pennsylvania, United States