Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00688402
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2008-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Compare Different Formulations of AZD3355
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545087', 'term': 'lesogaberan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific AE questions', 'timeFrame': 'During 0-4 hours post dose'}], 'secondaryOutcomes': [{'measure': 'PK variables', 'timeFrame': 'Frequent sampling up to 36 hours post dose'}, {'measure': 'Safety variables (other adverse events, blood pressure, pulse, safety lab)', 'timeFrame': 'During the whole treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reflux Inhibitor', 'GERD', 'formulations'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Female subjects with no childbearing potentials or using highly efficient contraceptive methods\n* Clinically normal physical findings\n\nExclusion Criteria:\n\n* Clinically significant illness within 2 weeks prior to the first dose of investigational product\n* History of clinically significant disease\n* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product'}, 'identificationModule': {'nctId': 'NCT00688402', 'briefTitle': 'Study to Compare Different Formulations of AZD3355', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D9120C00031'}, 'secondaryIdInfos': [{'id': 'EudraCT nr 2007-007126-22'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'IR Formulation 65 mg', 'interventionNames': ['Drug: AZD3355']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'IR Formulation 150 mg', 'interventionNames': ['Drug: AZD3355']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'MR formulation, 1h 65 mg', 'interventionNames': ['Drug: AZD3355']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'MR Formulation, 1h 150 mg', 'interventionNames': ['Drug: AZD3355']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'MR Formulation, 2h 150 mg', 'interventionNames': ['Drug: AZD3355']}], 'interventions': [{'name': 'AZD3355', 'type': 'DRUG', 'otherNames': ['Lesogaberan'], 'description': 'Single dose', 'armGroupLabels': ['1', '2', '3', '4', '5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Varvsgatan', 'state': 'Lulea', 'country': 'Sweden', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Eva Ersdal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Mölndal, Sweden'}, {'name': 'Aslak Rautio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}