Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT00776360
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2008-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oxytocin on the Gastric Emptying
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2008-10-17', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine whether oxytocin improves gastric emptying in gastroparesis', 'timeFrame': 'dec 2008-dec 22009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxytocin', 'gastroparesis', 'diabetics', 'The effect of oxytocin on gastric emptying'], 'conditions': ['Postprocedural Delayed Gastric Emptying']}, 'descriptionModule': {'briefSummary': 'The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.', 'detailedDescription': 'The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw. Once with saline and once with oxytocin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastroparesis in diabetics\n\nExclusion Criteria:\n\n* Treatment with other prokinetics, other severe organic or psychological diseases'}, 'identificationModule': {'nctId': 'NCT00776360', 'briefTitle': 'The Effect of Oxytocin on the Gastric Emptying', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis', 'orgStudyIdInfo': {'id': '29/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxytocin, gastric emptying', 'description': 'Oxytocin is given to study the gastric emptying rate', 'interventionNames': ['Drug: oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'oxytocin', 'description': 'sodium chloride is given to study gastric emptying rate', 'interventionNames': ['Drug: oxytocin']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'otherNames': ['syntocinon'], 'description': '80mIE/min as continuous infusion for 70 minutes', 'armGroupLabels': ['oxytocin', 'oxytocin, gastric emptying']}, {'name': 'oxytocin', 'type': 'DRUG', 'otherNames': ['syntocinon'], 'description': '80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy', 'armGroupLabels': ['oxytocin', 'oxytocin, gastric emptying']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Clinical Sciences, Division of Internal Medicine', 'investigatorFullName': 'Bodil Ohlsson', 'investigatorAffiliation': 'Skane University Hospital'}}}}