Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 9:52 PM
Study NCT ID:
NCT00813306
Status:
COMPLETED
Last Update Posted:
2010-12-07
First Post:
2008-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
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': 'C587779', 'term': 'AZD2066'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manometry', 'timeFrame': '3.45 hours each study period'}], 'secondaryOutcomes': [{'measure': 'pH', 'timeFrame': '3.45 hours each study period'}, {'measure': 'Impedance', 'timeFrame': '3.45 hours each study period'}, {'measure': 'Pharmacokinetic variables', 'timeFrame': '3.45 hours each study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'TLESR', 'reflux'], 'conditions': ['Reflux Episodes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written consent prior to any study specific procedures.\n* Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.\n* Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.\n* A measured LES pressure of \\< 5mm Hg.\n* History of previous or ongoing psychiatric disease/condition.'}, 'identificationModule': {'nctId': 'NCT00813306', 'briefTitle': '14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D9126C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'AZD2066', 'interventionNames': ['Drug: AZD2066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'AZD2066', 'interventionNames': ['Drug: AZD2066']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'AZD2066', 'interventionNames': ['Drug: AZD2066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD2066', 'type': 'DRUG', 'description': '13 mg oral solution, 1 single dose', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral solution, 1 single dose', 'armGroupLabels': ['B']}, {'name': 'AZD2066', 'type': 'DRUG', 'description': 'Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose', 'armGroupLabels': ['C']}, {'name': 'AZD2066', 'type': 'DRUG', 'description': 'Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose', 'armGroupLabels': ['D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral solution, 1 single dose', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Marie Sundin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Mölndal, Sweden'}, {'name': 'Guy E Boeckxstaens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Berner-Hansen, MD, PhDMedical Science Director, Early GI', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}