Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 11:01 AM
Study NCT ID:
NCT00878293
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Moldova']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily pain intensity', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['analgesic', 'diabetes mellitus', 'chronic neuropathic pain', 'painful polyneuropathy caused by diabetes mellitus type I or II'], 'conditions': ['Diabetic Polyneuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with pain at least NRS \\>4 due to painful diabetic polyneuropaty.\n\nExclusion Criteria:\n\n* Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.\n* non Caucasian or Hispanic.\n* Concomitant painful disease.\n* Life-long history of seizure disorder or epilepsy.\n* Subjects with clinical relevant cardiac and vascular diseases.\n* Subjects with impaired renal function\n* Subjects with impaired hepatic function\n* Female subjects who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT00878293', 'briefTitle': 'Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tris Pharma, Inc.'}, 'officialTitle': 'A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy', 'orgStudyIdInfo': {'id': '449723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Dose 1, 40 µg', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Dose 2, 120 µg', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Dose 3', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'Dose 4', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'description': 'Dose 5', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'F', 'description': 'Dose 6', 'interventionNames': ['Drug: GRT6005']}, {'type': 'EXPERIMENTAL', 'label': 'G', 'description': 'Dose 7', 'interventionNames': ['Drug: GRT6005']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'H', 'description': 'Morphin', 'interventionNames': ['Drug: MS Continus®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'I', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GRT6005', 'type': 'DRUG', 'description': 'liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days', 'armGroupLabels': ['A', 'B', 'C', 'D', 'E', 'F', 'G']}, {'name': 'MS Continus®', 'type': 'DRUG', 'description': '60 mg, capsule, once daily', 'armGroupLabels': ['H']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'liquid formulation and capsule, once daily', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Investigator 3', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Investigator 1', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Investigator 2', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Investigator 4', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Thomas Forst, Prof. Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IKFE, Parcusstr. 8, 55116 Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tris Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}