Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-10 @ 1:56 AM
Study NCT ID:
NCT00553592
Status:
UNKNOWN
Last Update Posted:
2007-11-05
First Post:
2007-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C034438', 'term': 'bicifadine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-02', 'studyFirstSubmitDate': '2007-11-01', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and Safety', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.xtlbio.com', 'label': "Sponsor's website"}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.\n\nTo compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years or older\n* Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus\n* Chronic bilateral pain due to diabetic neuropathy\n* Pain for at least six months\n* Primary pain is located in the feet\n* Others-contact site for information\n\nExclusion Criteria:\n\n* Symptoms of other painful conditions\n* Presence of amputations other than toes\n* Clinically significant psychiatric or other neurological disorder\n* Use of certain medications\n* Clinically important other diseases\n* Pregnancy\n* History of alcohol or narcotic abuse within two years\n* Others-contact site for information'}, 'identificationModule': {'nctId': 'NCT00553592', 'briefTitle': 'Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'XTL Biopharmaceuticals'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'XTL B07-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug', 'description': 'Bicifadine', 'interventionNames': ['Drug: Bicifadine']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: 2', 'description': 'Bicifadine', 'interventionNames': ['Drug: Bicifadine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo of Bicifadine', 'interventionNames': ['Drug: Bicifadine']}], 'interventions': [{'name': 'Bicifadine', 'type': 'DRUG', 'description': '600mg/day', 'armGroupLabels': ['Drug']}, {'name': 'Bicifadine', 'type': 'DRUG', 'description': 'placebo tablet', 'armGroupLabels': ['Control']}, {'name': 'Bicifadine', 'type': 'DRUG', 'description': '1200 mg', 'armGroupLabels': ['Drug: 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesse Wallace, MD', 'role': 'CONTACT', 'email': 'diargent@fourriversresearch.com', 'phone': '270-441-4606'}, {'name': 'Caron Massey', 'role': 'CONTACT', 'email': 'cmassey@fourriversresearch.com', 'phone': '270-441-4606'}, {'name': 'Jesse Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Four Rivers Clinical Research', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}], 'centralContacts': [{'name': 'Ivy Raso', 'role': 'CONTACT', 'email': 'iraso@xtlbio.com', 'phone': '845-267-0707', 'phoneExt': '222'}, {'name': 'Kevin Barnes, MT', 'role': 'CONTACT', 'email': 'kbarnes@incresearch.com', 'phone': '512-306-4254'}], 'overallOfficials': [{'name': 'Mark Roffman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'XTL Bio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XTL Biopharmaceuticals', 'class': 'INDUSTRY'}}}}