Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03477903
Status:
TERMINATED
Last Update Posted:
2019-09-24
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 days', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.', 'eventGroups': [{'id': 'EG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Daily Protein Adequacy Over the First 5 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 5', 'description': 'Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Average Daily Protein Adequacy Over the Study Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 14', 'description': 'Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 5', 'description': 'GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Average Daily Caloric Adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 5 and Days 1 to 14', 'description': 'Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Enteral Feeding Intolerance (EFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 14 or until resolution of EFI, whichever occurs first', 'description': 'Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving at Least 80% of Daily Goal Calories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 14 or end of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving at Least 80% of Daily Goal Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Days 1 to 14 or end of treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'type': 'SECONDARY', 'title': 'Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'timeFrame': 'Day 5 pre-dose', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'One participant took part in the study at an investigative site in the United States from 25-Aug-2018 to 29-Aug-2018.', 'preAssignmentDetails': 'One participant with a diagnosis of Enteral Feeding Intolerance (EFI) was enrolled and received 0.1 mg of TAK-954. No participants were enrolled in the other 3 planned arms of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligrams (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliters (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-28', 'size': 1015903, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-23T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Insufficient enrollment; No safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2018-03-19', 'resultsFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-23', 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Daily Protein Adequacy Over the First 5 Days of Treatment', 'timeFrame': 'Days 1 to 5', 'description': 'Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged.'}], 'secondaryOutcomes': [{'measure': 'Average Daily Protein Adequacy Over the Study Treatment Period', 'timeFrame': 'Days 1 to 14', 'description': 'Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged.'}, {'measure': 'Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment', 'timeFrame': 'Days 1 to 5', 'description': 'GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged.'}, {'measure': 'Average Daily Caloric Adequacy', 'timeFrame': 'Days 1 to 5 and Days 1 to 14', 'description': 'Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged.'}, {'measure': 'Time to Resolution of Enteral Feeding Intolerance (EFI)', 'timeFrame': 'Days 1 to 14 or until resolution of EFI, whichever occurs first', 'description': 'Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching.'}, {'measure': 'Percentage of Participants Achieving at Least 80% of Daily Goal Calories', 'timeFrame': 'Days 1 to 14 or end of treatment'}, {'measure': 'Percentage of Participants Achieving at Least 80% of Daily Goal Protein', 'timeFrame': 'Days 1 to 14 or end of treatment'}, {'measure': 'Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954', 'timeFrame': 'Day 5 pre-dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Critical Illness', 'Enteral Nutrition', 'Enteral Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.', 'detailedDescription': 'The drug being tested in this study is called TAK-954. The study will assess the treatment effect of intravenous TAK-954 in improving average daily protein adequacy received through enteral nutrition in critically ill participants with EFI.\n\nThe study will enroll approximately 200 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):\n\n* Group A: TAK-954 0.1 mg\n* Group B: TAK-954 0.3 mg\n* Group C: TAK-954 1 mg\n* Group D: Metoclopramide 10 mg\n\nThis multi-center trial will be conducted in the United States, United Kingdom, Australia and Canada. The overall duration of treatment in this study is maximum of 14 days while in hospital. Participants will be contacted by telephone 30 and 90 days after receiving their last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically (the tip of the tube must be in the body or the antrum of the stomach and not in the fundus).\n2. Is intubated and mechanically ventilated in the ICU.\n3. Is expected to remain alive, mechanically ventilated, and receive continuous enteral feeding for \\>=48 hours following randomization.\n4. Have EFI, defined as a single GRV measurement of \\>=250 mL with vomiting/retching within the last 24 hours, or a single GRV measurement of \\>=500 mL with or without vomiting/retching within the last 24 hours.\n\nExclusion Criteria:\n\n1. Is under consideration for withdrawal of life-sustaining treatments within the next 72 hours.\n2. Has had major esophageal or gastric surgery or direct luminal trauma on this admission (participants with lower abdominal surgery are not excluded unless enteral feeding is contraindicated).\n3. Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active gastric pacemaker.\n4. Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).\n5. Has been admitted primarily for treatment of a drug overdose.\n6. Has a presence of a post-pyloric tube in place at Randomization that may be used for enteral nutrition.\n7. Is receiving parenteral nutrition (PN) at Screening.\n8. Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.\n9. Has a different nutrient requirement than allowed in feeding protocol.(outside a range of 1.2 to 2 gram per kilogram per day \\[g/kg/day\\] of proteins and up to 1.5 kilocalorie per milliliter \\[kcal/mL\\]).'}, 'identificationModule': {'nctId': 'NCT03477903', 'briefTitle': 'TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance', 'orgStudyIdInfo': {'id': 'TAK-954-2002'}, 'secondaryIdInfos': [{'id': 'U1111-1208-1831', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2017-003206-41', 'type': 'EUDRACT_NUMBER'}, {'id': '18/NE/0139', 'type': 'REGISTRY', 'domain': 'NRES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: TAK-954 0.1 mg', 'description': 'TAK-954 0.1 milligram (mg), intravenously, administered as 60 minute-infusion, once daily along with 2 milliliter (mL) normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.', 'interventionNames': ['Drug: TAK-954', 'Drug: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: TAK-954 0.3 mg', 'description': 'TAK-954 0.3 mg, intravenously, administered as 60 minute-infusion, once daily along with 2 mL normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.', 'interventionNames': ['Drug: TAK-954', 'Drug: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: TAK-954 1.0 mg', 'description': 'TAK-954 1.0 mg, intravenously, administered as 60 minute-infusion, once daily along with 2 mL normal saline injection, intravenously, three times a day for a minimum of 5 days up to a maximum of 14 days.', 'interventionNames': ['Drug: TAK-954', 'Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D: Metoclopramide 10 mg', 'description': 'Metoclopramide 10 mg, injection, intravenously, three times a day along with 100 mL normal saline 60-minute infusion, intravenously, once daily for a minimum of 5 days up to a maximum of 14 days.', 'interventionNames': ['Drug: Metoclopramide', 'Drug: Normal Saline']}], 'interventions': [{'name': 'TAK-954', 'type': 'DRUG', 'description': 'TAK-954 infusion', 'armGroupLabels': ['Group A: TAK-954 0.1 mg', 'Group B: TAK-954 0.3 mg', 'Group C: TAK-954 1.0 mg']}, {'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Metoclopramide infusion', 'armGroupLabels': ['Group D: Metoclopramide 10 mg']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '0.9% sodium chloride for injection', 'armGroupLabels': ['Group A: TAK-954 0.1 mg', 'Group B: TAK-954 0.3 mg', 'Group C: TAK-954 1.0 mg', 'Group D: Metoclopramide 10 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Joseph M Still Burn Centers', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Eastern Idaho Medical Consultants', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '61606', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Lung & Critical Care Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Health Care', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Truman Medical Center 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