Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03784105
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2018-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Codeine on Pharyngeal and Esophageal Motility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}], 'ancestors': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003061', 'term': 'Codeine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in distal contractile integral', 'timeFrame': '1 week', 'description': 'The difference in distal contractile integral between the codeine and placebo condition'}, {'measure': 'Difference in integrated relaxation pressure', 'timeFrame': '1 week', 'description': 'The difference in integrated relaxation pressure between the codeine and placebo condition'}, {'measure': 'Difference in distal latency', 'timeFrame': '1 week', 'description': 'The difference in distal latency between the codeine and placebo condition.'}, {'measure': 'Difference in pressure flow', 'timeFrame': '1 week', 'description': 'The difference in pressure flow between the codeine and placebo condition'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['codeine', 'Esophageal motility', 'Pharyngeal motility'], 'conditions': ['Esophageal Motility Disorders']}, 'referencesModule': {'references': [{'pmid': '33232555', 'type': 'DERIVED', 'citation': 'Geeraerts A, Geysen H, Ballet L, Hofmans C, Clevers E, Omari T, Manolakis AC, Mols R, Augustijns P, Vanuytsel T, Rommel N, Tack J, Pauwels A. Codeine induces increased resistance at the esophagogastric junction but has no effect on motility and bolus flow in the pharynx and upper esophageal sphincter in healthy volunteers: A randomized, double-blind, placebo-controlled, cross-over trial. Neurogastroenterol Motil. 2021 May;33(5):e14041. doi: 10.1111/nmo.14041. Epub 2020 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged between 18-60 years old\n* Written informed consent\n\nExclusion Criteria:\n\n* No chronic disease/medication\n* No GI symptoms\n* Not pregnant or breast-feeding\n* No history of head/neck surgery\n* Not allergic to codeine'}, 'identificationModule': {'nctId': 'NCT03784105', 'briefTitle': 'Codeine on Pharyngeal and Esophageal Motility', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study', 'orgStudyIdInfo': {'id': 'S60496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Codeine', 'interventionNames': ['Drug: Codeine Phosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Siripus simplex', 'interventionNames': ['Drug: Siripus simplex']}], 'interventions': [{'name': 'Codeine Phosphate', 'type': 'DRUG', 'description': '30 mL of codeine phosphate 10mg/5mL', 'armGroupLabels': ['Codeine']}, {'name': 'Siripus simplex', 'type': 'DRUG', 'description': 'Sugar syrup', 'armGroupLabels': ['Siripus simplex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Jan Tack', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}