Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-08 @ 9:12 AM
Study NCT ID:
NCT00106860
Status:
COMPLETED
Last Update Posted:
2008-01-09
First Post:
2005-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2008-01-07', 'studyFirstSubmitDate': '2005-03-31', 'studyFirstSubmitQcDate': '2005-03-31', 'lastUpdatePostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD'}, {'measure': 'Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD'}]}, 'conditionsModule': {'keywords': ['Anxiety', 'Generalized Anxiety Disorder'], 'conditions': ['Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.', 'detailedDescription': 'This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complete Study 04-001-01\n* Able to take the medication for 9 months\n* Understand and sign the Informed Consent\n* Comply with all study-related procedures\n* Women of child bearing potential must have a confirmed negative urine pregnancy test\n* Lack of clinically significant abnormalities in health\n\nExclusion Criteria:\n\n* Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01\n* Early termination from study 04-001-01\n* Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements\n* Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.\n* Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial'}, 'identificationModule': {'nctId': 'NCT00106860', 'briefTitle': 'A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)', 'orgStudyIdInfo': {'id': '04-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'a benzodiazepine drug', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '08021', 'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CNS Research Institute (CRI)', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Midwest Clinical Research Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology and NeuroscienceCenter of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'IPS Research Company', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Clinical Research, Inc.', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19603', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Suburban Research Associates', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '19149', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CNS Research Institute (CRI)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Future Search Trials', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '22041', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Comprehensive Neuroscience of Northern Virginia', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Murray Stein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}}}}