Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-29 @ 2:08 AM
Study NCT ID:
NCT01263132
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuropathic Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D013831', 'term': 'Thiamine'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], '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': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Medical Responsible', 'organization': 'Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.', 'otherNumAtRisk': 38, 'otherNumAffected': 22, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.', 'otherNumAtRisk': 37, 'otherNumAffected': 23, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Limb Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Rhinopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Widespread Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Neuropathic Pain Score at Visit 3 (Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'OG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.00', 'spread': '17.39', 'groupId': 'OG000'}, {'value': '50.70', 'spread': '16.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 3 (Week 1)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'OG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'classes': [{'title': 'Baseline (Visit 2): General SF-36 QoL Index', 'categories': [{'measurements': [{'value': '53.044', 'spread': '22.409', 'groupId': 'OG000'}, {'value': '56.507', 'spread': '19.523', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (Visit 3): General SF-36 QoL Index', 'categories': [{'measurements': [{'value': '65.779', 'spread': '20.882', 'groupId': 'OG000'}, {'value': '65.610', 'spread': '18.599', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (Visit 4): General SF-36 QoL Index', 'categories': [{'measurements': [{'value': '69.531', 'spread': '18.987', 'groupId': 'OG000'}, {'value': '74.370', 'spread': '15.595', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (Visit 5): General SF-36 QoL Index', 'categories': [{'measurements': [{'value': '73.058', 'spread': '18.102', 'groupId': 'OG000'}, {'value': '78.075', 'spread': '15.819', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (Visit 6): General SF-36 QoL Index', 'categories': [{'measurements': [{'value': '78.869', 'spread': '17.010', 'groupId': 'OG000'}, {'value': '82.331', 'spread': '15.793', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) to Visit 6 (Week 4)', 'description': 'SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.'}, {'type': 'PRIMARY', 'title': 'Mean Neuropathic Pain Score at Visit 4 (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'OG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.24', 'spread': '16.21', 'groupId': 'OG000'}, {'value': '36.94', 'spread': '15.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Week 2)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.'}, {'type': 'PRIMARY', 'title': 'Mean Neuropathic Pain Score at Visit 5 (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'OG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.74', 'spread': '19.54', 'groupId': 'OG000'}, {'value': '24.86', 'spread': '13.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 5 (Week 3)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.'}, {'type': 'PRIMARY', 'title': 'Mean Neuropathic Pain Score at Visit 6 (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'OG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.08', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '17.29', 'spread': '15.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 6 (Week 4)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'FG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 104 participants were recruited for the study, out of which 29 participants were screen failures which were not randomized and did not receive study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin', 'description': 'Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'BG001', 'title': 'MF0434 + Gabapentin', 'description': 'MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '51.9', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2010-12-14', 'resultsFirstSubmitDate': '2011-09-19', 'studyFirstSubmitQcDate': '2010-12-17', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-19', 'studyFirstPostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Neuropathic Pain Score at Visit 3 (Week 1)', 'timeFrame': 'Visit 3 (Week 1)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.'}, {'measure': 'Mean Neuropathic Pain Score at Visit 4 (Week 2)', 'timeFrame': 'Visit 4 (Week 2)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.'}, {'measure': 'Mean Neuropathic Pain Score at Visit 5 (Week 3)', 'timeFrame': 'Visit 5 (Week 3)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.'}, {'measure': 'Mean Neuropathic Pain Score at Visit 6 (Week 4)', 'timeFrame': 'Visit 6 (Week 4)', 'description': 'Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire', 'timeFrame': 'Visit 2 (Baseline) to Visit 6 (Week 4)', 'description': 'SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polyneuropathy', 'Diabetes Mellitus', 'Diabetic peripheral neuropathy'], 'conditions': ['Diabetic Neuropathies', 'Polyneuropathies']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.', 'detailedDescription': 'Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.\n\nOBJECTIVES\n\n* To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with diabetes mellitus type 2\n* Subjects with a history of neuropathic pain in the last 3 Months\n* Men and women in reproductive age with a family planning method\n* Subjects aged between 18 to 70 years\n* Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%\n* Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit\n\nExclusion Criteria:\n\n* Subjects diagnosed as being pregnant or in state of lactation\n* Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min\n* Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes\n* Subjects who are being pharmacologically treated for epilepsy\n* Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes\n* Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study\n* Subjects with any orthopaedic alteration of any extremity\n* Subjects with peripheral artery disease\n* Subjects taking more than two neuropathic pain medicines\n* Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse\n* Subjects with acid-peptic disease\n* Subjects with history of neoplasm of any type'}, 'identificationModule': {'nctId': 'NCT01263132', 'acronym': 'M-F0434', 'briefTitle': 'Neuropathic Pain Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study', 'orgStudyIdInfo': {'id': '200057-500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F0434', 'interventionNames': ['Drug: F0434']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin', 'interventionNames': ['Drug: Gabapentin']}], 'interventions': [{'name': 'F0434', 'type': 'DRUG', 'otherNames': ['Gabapentin with thiamine and cobalamin'], 'description': 'F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).', 'armGroupLabels': ['F0434']}, {'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Gababion', 'Gavindo'], 'description': 'Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)', 'armGroupLabels': ['Gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Pachuca', 'state': 'Hidalgo', 'country': 'Mexico', 'facility': 'REMEDI Resultados Médicos Desarrollo e Investigación, S.C.', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck S.A. de C.V., Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck S.A. de C.V., Mexico', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}