Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-30 @ 8:51 AM
Study NCT ID:
NCT01122004
Status:
UNKNOWN
Last Update Posted:
2010-05-12
First Post:
2010-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-05-10', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain degree based on visual analog scale(VAS)'}]}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients candidate for PRK, 17\\<age\\<70\n\nExclusion Criteria:\n\n* use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding'}, 'identificationModule': {'nctId': 'NCT01122004', 'acronym': 'PRK', 'briefTitle': 'The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'armGroupLabels': ['Gabapentin']}, {'name': 'Pregabalin', 'type': 'DRUG', 'armGroupLabels': ['Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '166666', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Amir Faramarzi, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com'}], 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Amir faramarzi, MD', 'role': 'CONTACT', 'phone': '+982122585952'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}