Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-01 @ 9:19 AM
Study NCT ID:
NCT00439868
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2007-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2007-02-22', 'studyFirstSubmitQcDate': '2007-02-22', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure at Day -1, Days 1 & 14.', 'timeFrame': 'at Day -1, Days 1 & 14.'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure,Pupil diameter, anterior chamber angle', 'timeFrame': 'Days-1,1&14'}, {'measure': 'Wellbutrin XL plasma level', 'timeFrame': 'Days1,12-14'}, {'measure': 'adverse events', 'timeFrame': 'each visit'}, {'measure': 'lab tests,ECG,vital signs:', 'timeFrame': 'screening,followup'}, {'measure': 'lab tests:', 'timeFrame': 'Days-2,13-14'}, {'measure': 'ECG:', 'timeFrame': 'Day 14'}, {'measure': 'vital signs:', 'timeFrame': 'Days-2,-1,1,14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['WELLBUTRIN XL, intraocular pressure, healthy volunteers'], 'conditions': ['Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/WXL108709?search=study&search_terms=WXL108709#rs', 'label': 'Results for study WXL108709 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females.\n* Non-smokers\n* Agree to remain in the clinic for the time defined in the protocol.\n* Normal ECG.\n\nExclusion Criteria:\n\n* Any serious medical disorder or condition.\n* Any history of an endocrine disorder.\n* Any clinically significant laboratory abnormality.\n* History of psychiatric illness.\n* Any history of suicidal attempts or behavior.\n* Risk factors for precipitation of angle closure glaucoma or elevated IOP.\n* Inability to refrain from use of contact lenses during the study days, if correction is required.\n* Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.\n* Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.'}, 'identificationModule': {'nctId': 'NCT00439868', 'briefTitle': 'A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'WXL108709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'description': 'Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks.', 'interventionNames': ['Drug: WellbutrinXL', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'description': 'Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD.', 'interventionNames': ['Drug: WellbutrinXL', 'Drug: placebo']}], 'interventions': [{'name': 'WellbutrinXL', 'type': 'DRUG', 'description': 'WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.', 'armGroupLabels': ['Treatment Group 1', 'Treatment Group 2']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['WellbutrinXL'], 'description': 'Matching placebo tablets to WELLBUTRIN XL.', 'armGroupLabels': ['Treatment Group 1', 'Treatment Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}