Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
Study NCT ID:
NCT03617861
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2018-07-16
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Secretin in Functional Dyspepsia and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012633', 'term': 'Secretin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'camilleri.michael@mayo.edu', 'phone': '507-266-2305', 'title': 'Michael Camilleri, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postprandial fullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Satiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'categories': [{'measurements': [{'value': '892.5', 'groupId': 'OG000', 'lowerLimit': '892.5', 'upperLimit': '1011'}, {'value': '951.75', 'groupId': 'OG001', 'lowerLimit': '892.5', 'upperLimit': '1129.5'}, {'value': '655.5', 'groupId': 'OG002', 'lowerLimit': '537', 'upperLimit': '774'}, {'value': '892.5', 'groupId': 'OG003', 'lowerLimit': '655.5', 'upperLimit': '1011'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.65', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0574', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '60 minutes', 'description': 'Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fasting Gastric Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'categories': [{'measurements': [{'value': '171.28', 'groupId': 'OG000', 'lowerLimit': '146.17', 'upperLimit': '189.39'}, {'value': '152.96', 'groupId': 'OG001', 'lowerLimit': '145.5', 'upperLimit': '161.04'}, {'value': '227', 'groupId': 'OG002', 'lowerLimit': '186.7', 'upperLimit': '251.2'}, {'value': '210.2', 'groupId': 'OG003', 'lowerLimit': '179.38', 'upperLimit': '240.54'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.82', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1451', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Postprandial Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'categories': [{'measurements': [{'value': '435.85', 'groupId': 'OG000', 'lowerLimit': '384.70', 'upperLimit': '647.71'}, {'value': '457.43', 'groupId': 'OG001', 'lowerLimit': '329.39', 'upperLimit': '495.01'}, {'value': '593.80', 'groupId': 'OG002', 'lowerLimit': '557.85', 'upperLimit': '637.90'}, {'value': '582.36', 'groupId': 'OG003', 'lowerLimit': '546.51', 'upperLimit': '631.33'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4233', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes', 'description': 'Postprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Gastric Accommodation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'categories': [{'measurements': [{'value': '270.44', 'groupId': 'OG000', 'lowerLimit': '221.97', 'upperLimit': '468.01'}, {'value': '271.01', 'groupId': 'OG001', 'lowerLimit': '194.74', 'upperLimit': '343.62'}, {'value': '378.6', 'groupId': 'OG002', 'lowerLimit': '339.42', 'upperLimit': '404.18'}, {'value': '370.2', 'groupId': 'OG003', 'lowerLimit': '339.09', 'upperLimit': '382.06'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3891', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 30 minutes', 'description': 'The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gastric Emptying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10.0'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '26.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Healthy Secretin vs Healthy Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.03', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0355', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Healthy vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '30 minutes', 'description': 'Gastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.', 'unitOfMeasure': 'percentage of gastric emptying', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Postprandial Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls: Secretin', 'description': 'Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG001', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG002', 'title': 'Functional Dyspepsia: Secretin', 'description': 'Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.'}, {'id': 'OG003', 'title': 'Functional Dyspepsia: Placebo', 'description': 'Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '28'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '11'}]}]}, {'title': 'Fullness', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '31', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '42'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '33'}]}]}, {'title': 'Bloating', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '34'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '28'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '19'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '21'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Nausea: Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Nausea: Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Fullness: Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Fullness: Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Bloating: Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0330', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Bloating: Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.57', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2375', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Abdominal Pain: Healthy Controls vs Functional Dyspepsia', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 30 minutes', 'description': "30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls: Secretin Then Placebo', 'description': 'Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.'}, {'id': 'FG001', 'title': 'Healthy Controls: Placebo Then Secretin', 'description': 'Healthy subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.'}, {'id': 'FG002', 'title': 'Functional Dyspepsia: Secretin Then Placebo', 'description': 'Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.'}, {'id': 'FG003', 'title': 'Functional Dyspepsia: Placebo Then Secretin', 'description': 'Functional Dyspepsia subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout (1 to 4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls', 'description': 'Healthy controls were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.'}, {'id': 'BG001', 'title': 'Functional Dyspepsia', 'description': 'Functional Dyspepsia subjects were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'BG000', 'lowerLimit': '38.0', 'upperLimit': '49.0'}, {'value': '50.5', 'groupId': 'BG001', 'lowerLimit': '42.0', 'upperLimit': '55.0'}, {'value': '47.0', 'groupId': 'BG002', 'lowerLimit': '40.0', 'upperLimit': '52.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-19', 'size': 867311, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-16T11:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-01', 'studyFirstSubmitDate': '2018-07-16', 'resultsFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-01', 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Satiation', 'timeFrame': '60 minutes', 'description': 'Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.'}, {'measure': 'Fasting Gastric Volume', 'timeFrame': 'Baseline', 'description': 'Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).'}, {'measure': 'Postprandial Volume', 'timeFrame': '15 minutes', 'description': 'Postprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).'}, {'measure': 'Change in Gastric Accommodation', 'timeFrame': 'Baseline, 30 minutes', 'description': 'The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.'}, {'measure': 'Gastric Emptying', 'timeFrame': '30 minutes', 'description': 'Gastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.'}, {'measure': 'Change in Postprandial Symptoms', 'timeFrame': 'Baseline, 30 minutes', 'description': "30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspepsia', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '32036693', 'type': 'RESULT', 'citation': 'Brandler J, Miller LJ, Wang XJ, Burton D, Busciglio I, Arndt K, Harmsen WS, Camilleri M. Secretin effects on gastric functions, hormones and symptoms in functional dyspepsia and health: randomized crossover trial. Am J Physiol Gastrointest Liver Physiol. 2020 Apr 1;318(4):G635-G645. doi: 10.1152/ajpgi.00371.2019. Epub 2020 Feb 10.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Insights into the pathophysiology of functional dyspepsia, with recent demonstration of inflammation with eosinophilia and mastocytosis in the duodenum (3, 6, 7), providing a possible lead toward reduced secretion of a potential mediator of post-prandial gastric accommodation, the gastrointestinal peptide hormone secretin. The dominant site of synthesis and secretion of this hormone are enteroendocrine S cells in the duodenum. Inflammation-induced damage to these cells could produce a deficiency. Since intraluminal acid is a prominent stimulant of S cell secretion, the attempts to treat functional dyspepsia with anti-secretory medications could actually exacerbate a secretin deficiency syndrome. This raises the possibility of the therapeutic use of a secretin agonist or a positive allosteric modulator of the secretin receptor for patients with functional dyspepsia.', 'detailedDescription': 'The investigators will utilize single photon emission computed tomography (SPECT) methodology and gamma scintigraphy present in the GI laboratory of the outpatient Clinical Research Unit to study fasting gastric volumes and postprandial gastric accommodation responses and gastric emptying rates of a standardized meal in patients with functional dyspepsia and healthy subjects. Both groups will be studied twice, using crossover design, once with administration of secretin and once with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with FD and prior documentation of normal or accelerated gastric emptying and/or reduced gastric accommodation.\n\nInclusion criteria:\n\n* Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures\n* No medical problems or chronic diseases, other than functional dyspepsia, for that group\n* Body mass index of 18-35 kg/m2\n* Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record \\[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\\].\n\nExclusion criteria:\n\n* Unable or unwilling to provide informed consent or to comply with study procedures\n* Diagnosis of other gastrointestinal diseases besides functional dyspepsia\n* Structural or metabolic diseases that affect the GI system\n* Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:\n\n * Medications that alter GI transit or motor function including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, buspirone, clonidine, tricyclic antidepressants, and secretin-norepinephrine reuptake inhibitors\n * Analgesic drugs including NSAIDs and COX-2 inhibitors\n * NOTE: Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardio-protection, low stable dose antidepressants of the SSRI class, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted) are permissible.\n* History of recent surgery (within 60 days of screening)\n* Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.\n* Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator\n* Acute GI illness within 48 hours of initiation of the baseline period\n* Females who are pregnant or breastfeeding\n* History of excessive alcohol use or substance abuse\n* Participation in an investigational study within the 30 days prior to dosing in the present study\n* Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study'}, 'identificationModule': {'nctId': 'NCT03617861', 'briefTitle': 'Effect of Secretin in Functional Dyspepsia and Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effect of Secretin on Gastric Accommodation, Emptying and Post-nutrient Challenge Symptoms in Functional Dyspepsia and Healthy Subjects', 'orgStudyIdInfo': {'id': '18-003744'}, 'secondaryIdInfos': [{'id': 'R01DK115950', 'link': 'https://reporter.nih.gov/quickSearch/R01DK115950', 'type': 'NIH'}, {'id': 'R01DK122280', 'link': 'https://reporter.nih.gov/quickSearch/R01DK122280', 'type': 'NIH'}, {'id': 'UL1TR002377', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002377', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Controls: Secretin Then Placebo', 'description': 'Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.', 'interventionNames': ['Drug: Human Secretin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Controls: Placebo Then Secretin', 'description': 'Healthy subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.', 'interventionNames': ['Drug: Human Secretin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Functional Dyspepsia: Secretin Then Placebo', 'description': 'Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.', 'interventionNames': ['Drug: Human Secretin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Functional Dyspepsia: Placebo Then Secretin', 'description': 'Functional Dyspepsia subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.', 'interventionNames': ['Drug: Human Secretin', 'Drug: Placebo']}], 'interventions': [{'name': 'Human Secretin', 'type': 'DRUG', 'otherNames': ['ChiRhoStim'], 'description': 'Injected once over one minute', 'armGroupLabels': ['Functional Dyspepsia: Placebo Then Secretin', 'Functional Dyspepsia: Secretin Then Placebo', 'Healthy Controls: Placebo Then Secretin', 'Healthy Controls: Secretin Then Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Injected once over one minute', 'armGroupLabels': ['Functional Dyspepsia: Placebo Then Secretin', 'Functional Dyspepsia: Secretin Then Placebo', 'Healthy Controls: Placebo Then Secretin', 'Healthy Controls: Secretin Then Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Camilleri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Principal Investigator', 'investigatorFullName': 'Michael Camilleri, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}