M11_ProtocolSummary

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objectiveAndEstimandSummary

value: The primary objective of this study is to see if Inhaled Exoticillin achieves similar or better results compared to intramuscular Exoticillin when treating Bronchtis in Japanese Patients who also have Iatrogenic Diabetes Mellitus. The seconday objective is to evaluate the cost differences in treatment. Evaluation will be by recording the average days to recovery, the total combined cost of medication and cost of hospital stay.

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interventionModel

value: Parallel Group

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populationType

value: With Disease

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controlType

value: Different Dose or Regimen

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comparator

value: MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2010/12

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minimumAge

value: 18 Years (Details: NCI Thesaurus codeC29848 = 'C29848')

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maximumAge

value: 55 Years (Details: NCI Thesaurus codeC29848 = 'C29848')

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interventionAssignmentMethod

value: Randomisation

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randomisationType

value: block randomisation

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otherInterventionAssignmentMethod

value:

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stratificationIndicator

value: Yes

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siteDistribution

value: Multicentre

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siteGeographicScope

value: Multiple Countries

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masterProtocolIndicator

value: No

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drug-DeviceCombinationProductIndicator

value: Yes

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adaptiveTrialDesignIndicator

value: No

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numberOfArms

value: 2

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trialBlindSchema

value: Observer Blind

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blindedRoles

value: Participant

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blindedRoles

value: Care Provider

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targetOrMaximum

value: Target

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numberOfParticipants

value: 200

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alternateDescriptionOfPlannedDurationOfTrialIntervention

value: Will depend on response to treatment

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totalPlannedDurationOfTrialParticipation

value: 3 Months (Details: NCI Thesaurus codeC29846 = 'C29846')

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independentCommittees

value: Independent Data Monitoring Committee

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independentCommittees

value: Other

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otherCommittees

value: Exemplar Monitoring Board

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trialSchema

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schemaNotes

value: Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \"lorem ipsum\" incipiunt, sed ita translatae non sunt textus laetus.

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scheduleofActivities

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populationDiagnosisOrCondition

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unitsOfMinimumAge

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unitsOfMaximumAge

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totalPlannedDurationOfTrialIntervention

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alternateDescriptionOfPlannedDurationOfTrialParticipation

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additionalDescriptionofDuration

M11 Research Study Extension

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originalProtocol

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versionDate

identifier: Sponsor Protocol Identifier/ABC-Exemplar (use: usual, )

status: Active

Focus

condition: Bronchitis (disorder), Iatrogenic hypoglycaemia