Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 6:28 AM
Study NCT ID:
NCT00778193
Status:
COMPLETED
Last Update Posted:
2008-10-23
First Post:
2008-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-22', 'studyFirstSubmitDate': '2008-07-24', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSAID', 'ulcer', 'gastroduodenal ulcer', 'naproxen', 'aspirin', 'ASA', 'celecoxib', 'clopidogrel', 'healing', 'Cyclooxygenase 2 Inhibitors', 'Anti-Inflammatory Agents, Non-Steroidal', 'Platelet Aggregation Inhibitors', 'Wound Healing'], 'conditions': ['Gastroduodenal Ulcer']}, 'referencesModule': {'references': [{'pmid': '18224442', 'type': 'BACKGROUND', 'citation': 'Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.', 'detailedDescription': 'In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated.\n\nAfter all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Age 18-75\n* Use of appropriate form of birth control for women of childbearing potential.\n\nExclusion Criteria:\n\n* H pylori infection\n* Use of NSAIDs within 2 weeks prior to start of enrollment\n* Use of antacids or H-2 blockers within 2 weeks of enrollment\n* Use of PPIs within 30 days of enrollment\n* Corticosteroid use within 60 days of enrollment\n* History of a previous ulcer\n* Diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment\n* Use of cigarettes within 6 months of enrollment\n* Consumption of \\>3 alcoholic beverages per day\n* Hypersensitivity or allergy to NSAIDs, clopidogrel, or corn starch, or any contraindications to ingesting those substances\n* The presence of an ulcer at a baseline endoscopy\n* Endoscopically severe gastritis or duodenitis baseline endoscopy\n* Moderate or severe inflammation located within the duodenal bulb or within 2cm of the pyloric channel at a baseline endoscopy\n* Any gastroduodenal tumor.'}, 'identificationModule': {'nctId': 'NCT00778193', 'acronym': 'Lesions2', 'briefTitle': 'Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Research Associates of New York, LLP'}, 'officialTitle': 'A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing', 'orgStudyIdInfo': {'id': 'Healing Study'}, 'secondaryIdInfos': [{'id': 'GA319181'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen', 'interventionNames': ['Drug: Naproxen']}, {'type': 'EXPERIMENTAL', 'label': 'Aspirin', 'interventionNames': ['Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Clopidogrel', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'interventionNames': ['Drug: Celecoxib']}], 'interventions': [{'name': 'Naproxen', 'type': 'DRUG', 'otherNames': ['naprosyn', 'naproxen sodium', 'Aleve', 'Anaprox', 'Miranax', 'Naprogesic', 'Naprelan', 'Proxen', 'Synflex'], 'description': '1 tablet 500mg BID for 8 days', 'armGroupLabels': ['Naproxen']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['ASA', 'Bayer'], 'description': '1 tablet 81mg QD for 8 days', 'armGroupLabels': ['Aspirin']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': '1 capsule 200mg QD for 8 days', 'armGroupLabels': ['Celecoxib']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days', 'armGroupLabels': ['Clopidogrel']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': '1 capsule BID for 8 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James Aisenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Associates of New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Associates of New York, LLP', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'James Asienberg, MD', 'oldOrganization': 'Research Associates of New York'}}}}