Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-06-26 @ 4:57 AM
Study NCT ID:
NCT01383694
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Piperine In Patients With Oropharyngeal Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008922', 'term': 'piperine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of swallow', 'timeFrame': '15 minutes', 'description': 'Prevalence of penetrations at the laryngeal vestibule'}], 'secondaryOutcomes': [{'measure': 'Efficacy of swallow', 'timeFrame': '15 minutes', 'description': 'Prevalence of oral and pharyngeal residue'}]}, 'conditionsModule': {'conditions': ['Deglutition Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://link.springer.com/article/10.1007%2Fs00535-013-0920-0', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': 'Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing of dysphagic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases)\n* Study explained and written subject information given\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media\n* Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study\n* Patients with a background of alcohol dependence or other drug dependence\n* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study'}, 'identificationModule': {'nctId': 'NCT01383694', 'acronym': 'FIS 2009_2', 'briefTitle': 'Effect Of Piperine In Patients With Oropharyngeal Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Mataró'}, 'officialTitle': 'Effect of Natural Agonists of TRPV1 in the Treatment of Functional Oropharyngeal Dysphagia in Neurological Diseases and the Elderly: Piperine', 'orgStudyIdInfo': {'id': 'FIS 22/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piperine Dose 1', 'description': 'Piperine 1 mM', 'interventionNames': ['Drug: Piperine']}, {'type': 'EXPERIMENTAL', 'label': 'Piperine Dose 2', 'description': 'Piperine 150 microM', 'interventionNames': ['Drug: Piperine']}], 'interventions': [{'name': 'Piperine', 'type': 'DRUG', 'armGroupLabels': ['Piperine Dose 1', 'Piperine Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Mataró', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Pere Clave', 'investigatorAffiliation': 'Hospital de Mataró'}}}}