Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT00799656
Status:
COMPLETED
Last Update Posted:
2011-04-01
First Post:
2008-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515616', 'term': '5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-31', 'studyFirstSubmitDate': '2008-11-27', 'studyFirstSubmitQcDate': '2008-11-28', 'lastUpdatePostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average daily pain intensity', 'timeFrame': 'after 28-days treatment'}], 'secondaryOutcomes': [{'measure': 'Responder rate', 'timeFrame': 'after 28-days treatment'}, {'measure': 'Rescue medication intake', 'timeFrame': 'during 28-days treatment'}, {'measure': 'Change in Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'after 28-days treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic neuropathy', 'painful pain', 'postoperative'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.\n\nThe secondary objective is to assess the safety and tolerability of ataciguat versus placebo.', 'detailedDescription': 'This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.\n\nExclusion Criteria:\n\n* Presence or history of cancer within the past five years\n* Patients with a history of HIV infection\n* Patients with active hepatitis B or C\n* Patients with any pain other than the neuropathic pain of greater or equal severity\n* Patients with a diabetes mellitus for less than 6 months\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00799656', 'acronym': 'SERENEATI', 'briefTitle': 'Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study', 'orgStudyIdInfo': {'id': 'DFI10569'}, 'secondaryIdInfos': [{'id': 'EudraCT 2008-001518-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'First period: Ataciguat - Second period: Placebo', 'interventionNames': ['Drug: ataciguat (HMR1766)', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'First period: Placebo - Second period: Ataciguat', 'interventionNames': ['Drug: ataciguat (HMR1766)', 'Drug: placebo']}], 'interventions': [{'name': 'ataciguat (HMR1766)', 'type': 'DRUG', 'description': 'oral administration 200mg once daily for 28 days', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration once daily for 28 days', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Hans-Goerg Kress, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}