Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 11:14 PM
Study NCT ID:
NCT00628667
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid', 'timeFrame': 'Dialy diary cards, investigator assessments, laryngoscopy at week 16'}], 'secondaryOutcomes': [{'measure': 'Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux.', 'timeFrame': 'Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16'}, {'measure': 'Quality of life Questionnaire', 'timeFrame': 'Quality of life questionnaire completed at screening and week 16'}, {'measure': 'To evaluate the safety and tolerability by collecting an ongoing record of adverse events.', 'timeFrame': 'Ongoing to week 16.'}]}, 'conditionsModule': {'keywords': ['Chronic Posterior Laryngitis', 'CPL', 'Pharyngeal acid reflux', 'Esomeprazole', 'Nexium'], 'conditions': ['Chronic Posterior Laryngitis (CPL)']}, 'descriptionModule': {'briefSummary': 'This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.\n* Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.\n* Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.\n\nExclusion Criteria:\n\n* A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.\n* If the patient is on certain medications this will also preclude them from taking part.'}, 'identificationModule': {'nctId': 'NCT00628667', 'briefTitle': 'Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux', 'orgStudyIdInfo': {'id': 'SH-NEE-0002'}, 'secondaryIdInfos': [{'id': 'D9611C00002'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': '40mg orally twice daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paula Fernstrom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nexium Global Product Director, AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind, MD - Nexium Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}