Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-11 @ 8:57 PM
Study NCT ID:
NCT00660868
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2008-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Pentoxifylline Able to Improve Olfactory Sensitivity?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D000086582', 'term': 'Anosmia'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TDI-score', 'timeFrame': 'at day 0 and follow up after 3 weeks'}], 'secondaryOutcomes': [{'measure': 'odor threshold odor discrimination odor identification', 'timeFrame': 'at day 0 and at follow up after 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smell', 'olfaction', 'olfactory sensitivity', 'smell loss', 'chemoreception'], 'conditions': ['Olfaction Disorders']}, 'descriptionModule': {'briefSummary': 'Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.', 'detailedDescription': 'Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hyposmic or functionally anosmic patients TDI-score \\<31; age: 18-50 years; odor threshold: better than 1; cause of smell loss: post traumatic, postinflammatory, idiopathic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hyposmic or functionally anosmic patients TDI-score \\<31\n* age: 18-50 years\n* odor threshold: better than 1\n* cause of smell loss: post traumatic, postinflammatory, idiopathic\n\nExclusion Criteria:\n\n* normosmic patients,\n* patients with contraindications for application of pentoxifylline\n* patients that cannot give written agreement to the study\n* patients under 18 years and over 50 years of age'}, 'identificationModule': {'nctId': 'NCT00660868', 'briefTitle': 'Is Pentoxifylline Able to Improve Olfactory Sensitivity?', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study', 'orgStudyIdInfo': {'id': 'EK157072007'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1.', 'interventionNames': ['Drug: Pentoxifylline retard 400mg']}], 'interventions': [{'name': 'Pentoxifylline retard 400mg', 'type': 'DRUG', 'otherNames': ['Agapurin retard'], 'description': 'Agapurin retard 400mg 3/day per os for 3 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Volker Gudziol, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universität Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}