Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT02074267
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of pain intensity using the visual analog scale (VAS)', 'timeFrame': 'up to six weeks'}]}, 'conditionsModule': {'conditions': ['Neuropathy', 'Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \\& Neurontin) in patients with neuropathy pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1.\n* Subjects must be 20 years of age or older.\n\nExclusion Criteria:\n\n* Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.\n* Subjects who have a clinically significant or unstable medical or psychiatric condition.\n* Subjects who are known of hypersensitivity to Gabapentin.\n* Serum creatinine \\> 1.5 times the upper limit of normal\n* Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.\n* Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).\n* Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.\n* Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.'}, 'identificationModule': {'nctId': 'NCT02074267', 'briefTitle': 'Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nang Kuang Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'S08174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbatin', 'description': 'Carbatin is initiated at 100 mg at night and slowly titrated to 300\\~800 mg three times/day over 4 to 25 days', 'interventionNames': ['Drug: Carbatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neurontin', 'description': 'Neurontin is initiated at 100 mg at night and slowly titrated to 300\\~800 mg three times/day over 4 to 25 days', 'interventionNames': ['Drug: Neurontin']}], 'interventions': [{'name': 'Carbatin', 'type': 'DRUG', 'description': 'Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300\\~800 mg three times/day over 4 to 25 days.\n\nThe dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.', 'armGroupLabels': ['Carbatin']}, {'name': 'Neurontin', 'type': 'DRUG', 'description': 'Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300\\~800 mg three times/day over 4 to 25 days.\n\nThe dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.', 'armGroupLabels': ['Neurontin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '712', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Nang Kuang Pharmaceutical Co., LTD', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nang Kuang Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}