Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT00904202
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2009-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511998', 'term': 'Lidoderm'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'lastUpdateSubmitDate': '2023-12-29', 'studyFirstSubmitDate': '2009-05-15', 'studyFirstSubmitQcDate': '2009-05-18', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily pain intensity (BPI Questions 3,4,5, and 6)', 'timeFrame': 'Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)'}], 'secondaryOutcomes': [{'measure': 'Pain Quality Assessment Scale (PQAS)'}, {'measure': 'Investigator and Patient Global Impression of Change'}, {'measure': 'Allodynia Testing'}, {'measure': 'QoL; Symptom Checklist, pain interference with QoL'}, {'measure': 'Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)'}, {'measure': 'Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postherpetic Neuralgia', 'Diabetic Neuropathy', 'Complex Regional Pain Syndrome', 'Carpal Tunnel Syndrome', 'HIV Neuropathy', 'Idiopathic Sensory Neuropathy', 'Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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)\n2. Patients with PHN must have had pain \\>3 months after rash healing\n3. 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\n4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria\n5. 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\n6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration\n7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration\n8. 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)\n9. Had never received an analgesic regimen that contained lidocaine or gabapentin\n\nExclusion Criteria:\n\n1. 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\n2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine\n3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)"}, 'identificationModule': {'nctId': 'NCT00904202', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EN3220-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo capsules + placebo patch', 'description': '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', 'interventionNames': ['Drug: Placebo Capsules + Placebo Patch']}, {'type': 'EXPERIMENTAL', 'label': 'placebo capsules + Lidoderm patch (Lidocaine Group)', 'description': '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', 'interventionNames': ['Drug: Placebo capsules + Lidoderm®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin capsules 1800 mg/day + placebo patch', 'description': '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', 'interventionNames': ['Drug: Gabapentin + Placebo', 'Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch']}, {'type': 'OTHER', 'label': 'Gabapentin capsules 1800 mg/day + Lidoderm patch', 'description': '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', 'interventionNames': ['Drug: Gabapentin + Lidoderm®', 'Drug: Gabapentin 1800 mg/day + Lidoderm patch']}], 'interventions': [{'name': 'Placebo Capsules + Placebo Patch', 'type': 'DRUG', 'otherNames': ['Lidocaine patch 5%'], 'description': '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).', 'armGroupLabels': ['placebo capsules + placebo patch']}, {'name': 'Placebo capsules + Lidoderm®', 'type': 'DRUG', 'otherNames': ['Lidocaine patch 5%'], 'description': '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).', 'armGroupLabels': ['placebo capsules + Lidoderm patch (Lidocaine Group)']}, {'name': 'Gabapentin + Placebo', 'type': 'DRUG', 'otherNames': ['Lidocaine patch 5%'], 'description': '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).', 'armGroupLabels': ['Gabapentin capsules 1800 mg/day + placebo patch']}, {'name': 'Gabapentin + Lidoderm®', 'type': 'DRUG', 'otherNames': ['Lidocaine patch 5%'], 'description': '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).', 'armGroupLabels': ['Gabapentin capsules 1800 mg/day + Lidoderm patch']}, {'name': 'Gabapentin 300 mg capsules 1800 mg/day + placebo patch', 'type': 'DRUG', 'description': 'Gabapentin 300 mg capsules 1800 mg/day + placebo patch', 'armGroupLabels': ['Gabapentin capsules 1800 mg/day + placebo patch']}, {'name': 'Gabapentin 1800 mg/day + Lidoderm patch', 'type': 'DRUG', 'armGroupLabels': ['Gabapentin capsules 1800 mg/day + Lidoderm patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Hueytown', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.45122, 'lon': -86.99666}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}], 'overallOfficials': [{'name': 'Sr Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sr Director, Clinical R&D', 'oldOrganization': 'Endo Pharmaceuticals Inc'}}}}