Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-27 @ 1:40 PM
Study NCT ID:
NCT00475904
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2007-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sallard@epicept.com', 'phone': '914-606-3500', 'title': 'Chief Medical Officer', 'organization': 'EpiCept Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules', 'description': 'amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily', 'otherNumAtRisk': 140, 'otherNumAffected': 7, 'seriousNumAtRisk': 140, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Gabapentin Capsules, Placebo Cream', 'description': 'oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily', 'otherNumAtRisk': 144, 'otherNumAffected': 2, 'seriousNumAtRisk': 144, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Cream and Capsules', 'description': 'placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily', 'otherNumAtRisk': 76, 'otherNumAffected': 1, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules', 'description': 'amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily'}, {'id': 'OG001', 'title': 'Gabapentin Capsules, Placebo Cream', 'description': 'oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily'}, {'id': 'OG002', 'title': 'Placebo Cream and Capsules', 'description': 'placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.424', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '2.78'}, {'value': '2.471', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '2.77'}, {'value': '1.877', 'groupId': 'OG002', 'lowerLimit': '1.43', 'upperLimit': '2.32'}]}]}], 'analyses': [{'pValue': '0.0441', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.547', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.08', 'pValueComment': 'a priori threshold for statistical significance was p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2709', 'groupDescription': 'In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 28 days', 'description': 'Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.'}, {'type': 'PRIMARY', 'title': 'Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules', 'description': 'amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily'}, {'id': 'OG001', 'title': 'Gabapentin Capsules, Placebo Cream', 'description': 'oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily'}, {'id': 'OG002', 'title': 'Placebo Cream and Capsules', 'description': 'placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.424', 'groupId': 'OG000', 'lowerLimit': '2.07', 'upperLimit': '2.7'}, {'value': '2.471', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '2.77'}, {'value': '1.877', 'groupId': 'OG002', 'lowerLimit': '1.43', 'upperLimit': '2.3'}]}]}], 'analyses': [{'pValue': '0.8409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.046', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.43', 'pValueComment': 'To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.2311', 'groupDescription': 'the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline to 28 Days', 'description': 'Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules', 'description': 'amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily'}, {'id': 'FG001', 'title': 'Gabapentin Capsules, Placebo Cream', 'description': 'oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily'}, {'id': 'FG002', 'title': 'Placebo Cream and Capsules', 'description': 'placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules', 'description': 'amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily'}, {'id': 'BG001', 'title': 'Gabapentin Capsules, Placebo Cream', 'description': 'oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily'}, {'id': 'BG002', 'title': 'Placebo Cream and Capsules', 'description': 'placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '16.04', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '15.53', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '16.47', 'groupId': 'BG002'}, {'value': '52.5', 'spread': '15.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2007-05-17', 'resultsFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2007-05-18', 'lastUpdatePostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-09', 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.', 'timeFrame': 'baseline and 28 days', 'description': 'Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.'}, {'measure': 'Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin', 'timeFrame': 'baseline to 28 Days', 'description': 'Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post Herpetic Neuralgia', 'PHN', 'Neuropathy', 'Nerve Pain', 'Topical'], 'conditions': ['Post Herpetic Neuralgia', 'PHN', 'Neuropathy', 'Nerve Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)', 'detailedDescription': 'This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash\n\nExclusion Criteria:\n\n* Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.'}, 'identificationModule': {'nctId': 'NCT00475904', 'briefTitle': 'A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EpiCept Corporation'}, 'officialTitle': 'A Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)', 'orgStudyIdInfo': {'id': 'EPC2007-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'amitriptyline 4% ketamine 2% cream, placebo capsules', 'description': 'Np-1 cream and placebo gabapentin', 'interventionNames': ['Drug: EpiCept-NP-1 Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gabapentin capsules, placebo cream', 'description': 'gabapentin caps and placebo cream', 'interventionNames': ['Drug: Gabapentin Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo cream and capsules', 'description': 'placebo cream and capsules', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'EpiCept-NP-1 Cream', 'type': 'DRUG', 'description': 'ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks', 'armGroupLabels': ['amitriptyline 4% ketamine 2% cream, placebo capsules']}, {'name': 'Gabapentin Capsules', 'type': 'DRUG', 'otherNames': ['gabapentin, neurontin'], 'description': '1800mg/day capsules for 4 weeks', 'armGroupLabels': ['gabapentin capsules, placebo cream']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['vehicle cream, placebo capsules'], 'description': 'placebo cream and caps', 'armGroupLabels': ['placebo cream and capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'New Delhi', 'country': 'India', 'facility': 'Multiple Centers', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Robert H Dworkin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EpiCept Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Stephane Allard, Chief Medical Officer', 'oldOrganization': 'EpiCept Corporation'}}}}