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:
|
Cumulative Trauma Disorders 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 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 May 16, 2013