Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01161602
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2010-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
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': 'C482040', 'term': 'Pumosetrag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-05'}, 'lastUpdateSubmitDate': '2011-09-20', 'studyFirstSubmitDate': '2010-07-12', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Symptoms of Gastroesophageal Reflux Disease (GERD)'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).\n* Between ages of 18 - 70 inclusive.\n* Develop GERD symptoms following ingestion of a refluxogenic meal.\n* Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.\n* Understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Allergic to pumosetrag or formulation excipients.'}, 'identificationModule': {'nctId': 'NCT01161602', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edusa Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal', 'orgStudyIdInfo': {'id': 'Pumo-10-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.2mg Pumosetrag', 'interventionNames': ['Drug: Pumosetrag']}, {'type': 'EXPERIMENTAL', 'label': '0.5mg Pumosetrag', 'interventionNames': ['Drug: Pumosetrag']}, {'type': 'EXPERIMENTAL', 'label': '0.8mg Pumosetrag', 'interventionNames': ['Drug: Pumosetrag']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pumosetrag', 'type': 'DRUG', 'armGroupLabels': ['0.2mg Pumosetrag']}, {'name': 'Pumosetrag', 'type': 'DRUG', 'armGroupLabels': ['0.5mg Pumosetrag']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}, {'name': 'Pumosetrag', 'type': 'DRUG', 'armGroupLabels': ['0.8mg Pumosetrag']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edusa Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}