Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00637793
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2008-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C470586', 'term': '(S)-2-ethyl-8-methyl-1-thia-4,8-diazaspiro(4.5)decan-3-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-28', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2009-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative and qualitative assessment of dry mouth', 'timeFrame': '36 days'}], 'secondaryOutcomes': [{'measure': 'Tolerability and safety of NGX267', 'timeFrame': '36 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xerostomia', "Sjogren's Syndrome"], 'conditions': ['Xerostomia', "Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.\n\nFor each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.\n* Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.\n* Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.\n* Patients must not be in an acute phase of illness.\n\nExclusion Criteria:\n\n* Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.\n* Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.\n* Patients who are otherwise judged inappropriate for inclusion in the study by the investigator\n* Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.\n* Patients who are allergic to compounds that are similar to NGX267."}, 'identificationModule': {'nctId': 'NCT00637793', 'briefTitle': "Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'TorreyPines Therapeutics'}, 'officialTitle': "A Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's Syndrome", 'orgStudyIdInfo': {'id': 'NGX267XSS2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo capsules', 'interventionNames': ['Drug: NGX267']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '2 capsules in the am of each treatment period', 'interventionNames': ['Drug: NGX267']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '2 capsules in the am of each treatment period', 'interventionNames': ['Drug: NGX267']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '2 capsules in am of each treatment period', 'interventionNames': ['Drug: NGX267']}], 'interventions': [{'name': 'NGX267', 'type': 'DRUG', 'description': '2 capsules in the am of each treatment period', 'armGroupLabels': ['2']}, {'name': 'NGX267', 'type': 'DRUG', 'description': '2 capsules in the am of each treatment period', 'armGroupLabels': ['3']}, {'name': 'NGX267', 'type': 'DRUG', 'description': '2 capsules in the am of each treatment period', 'armGroupLabels': ['1']}, {'name': 'NGX267', 'type': 'DRUG', 'description': '2 capsules in the am of each treatment period', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn Rheumatology Associates and Sjogren's Syndrome Center", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Walter F. Chase MD PA', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Walter F. Chase, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter F. Chase MD. PA'}, {'name': 'Alan Kivitz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altoona Center for Clinical Research'}, {'name': 'Frederick B. Vivino, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Penn Rheumatology Associates and Sjogren's Syndrome Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TorreyPines Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Susan Mellberg, R.N., M.B.A.; VP, Project Management', 'oldOrganization': 'TorreyPines Therapeutics, Inc.'}}}}