Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT01000220
Status:
UNKNOWN
Last Update Posted:
2010-05-04
First Post:
2009-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Omeprazole Effect on Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-05-03', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.', 'detailedDescription': 'Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with glaucoma\n* 18 to 70 years\n* POAG patients, Pseudoexfoliation\n* no history of other systemic disease\n* no history of intraocular intervention\n* no history of H2 blocker or PPI consumption during the past month consuming 2 or less topical anti-glaucoma medication\n* no present immune deficiency\n* no addiction habit\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01000220', 'briefTitle': 'Evaluation of Omeprazole Effect on Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Evaluation of Omeprazole Effect on Glaucoma', 'orgStudyIdInfo': {'id': '8735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole', 'interventionNames': ['Drug: Omeprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'armGroupLabels': ['Omeprazole']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '166666', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Shahin yazdani, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '+98 21 22585952'}], 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Yazdani Shahin, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '+982122585952'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ophthalmic Research Center', 'class': 'AMBIG'}], 'responsibleParty': {'oldOrganization': 'Ophthalmic Research Center'}}}}