Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT00904020
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 the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain
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': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'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': 'D001416', 'term': 'Back Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511998', 'term': 'Lidoderm'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, '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': '2002-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}], 'secondaryOutcomes': [{'measure': 'Pain quality using the Neuropathic Pain Scale (NPS)', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'Investigator and Patient Global Impression of Change', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'Extent of numbness at the site of pain using the Numbness Questionnaire', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'Patient Global Assessment of Pain Relief', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'QoL: Pain interference (BPI Question 9)', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}, {'measure': 'QoL: Patient Global Assessment of Patch Satisfaction', 'timeFrame': 'Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)'}]}, 'conditionsModule': {'conditions': ['Postherpetic Neuralgia', 'Diabetic Neuropathy', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Were currently receiving an analgesic regimen that contained gabapentin\n* Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)\n* Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of \\>4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory \\[BPI\\] within 24 hours prior to the screening visit\n* For diabetic patients, had a hemoglobin A1c level \\<0.13 (normal range, 0.047-0.064)\n\nExclusion Criteria:\n\n* Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study\n* Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry\n* Had received trigger point injections within 14 days prior to study entry\n* Had received Botox injections within 3 months prior to study entry\n* Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm\n* Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)'}, 'identificationModule': {'nctId': 'NCT00904020', 'briefTitle': 'A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain', 'orgStudyIdInfo': {'id': 'EN3220-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(1) Lidoderm', 'description': '(1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.', 'interventionNames': ['Drug: Lidoderm']}], 'interventions': [{'name': 'Lidoderm', 'type': 'DRUG', 'otherNames': ['Lidocaine patach 5%'], 'description': 'Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.', 'armGroupLabels': ['(1) Lidoderm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Burr Ridge', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.74892, 'lon': -87.91839}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'city': 'Cudahy', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.95974, 'lon': -87.86147}}, {'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}, {'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}], 'overallOfficials': [{'name': 'Study 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.'}}}}