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:
Endo Pharmaceuticals
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904202
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
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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:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics:
Carpal Tunnel Syndrome
Complex Regional Pain Syndrome
Diabetic Nerve Problems
HIV/AIDS
Peripheral Nerve Disorders
Shingles
U.S. FDA Resources
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:
- 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)
Contacts and Locations
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:
|
Peripheral Nervous System Diseases Demyelinating Diseases Neuromuscular Diseases Nervous System Diseases Cumulative Trauma Disorders Endocrine System Diseases Substance-Related Disorders Autonomic Nervous System Diseases Carpal Tunnel Syndrome Diabetic Neuropathies Neuralgia Neuralgia, Postherpetic Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations |
Neurotoxicity Syndromes Complex Regional Pain Syndromes Median Neuropathy Mononeuropathies Sprains and Strains Wounds and Injuries Diabetes Complications Diabetes Mellitus Pain Signs and Symptoms Poisoning Lidocaine Gabapentin Gamma-Aminobutyric Acid Anesthetics, Local |
ClinicalTrials.gov processed this record on May 19, 2013