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ICI35, 868

Phase 2

Gastrointestinal Endoscopy | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Dec 19, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

ICI35, 868 · 1 trial · 2 indications

Phase 2 1
NCT01189604Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic TestsGastrointestinal Endoscopy
COMPLETED123 Analytics
PHASE2COMPLETED
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Gastrointestinal EndoscopyUnlock trial analytics

Study Endpoints

Primary Endpoints

Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
2 minutes from the beginning of the maintenance period

The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.

Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
4 minutes from the beginning of the maintenance period

The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.

Secondary Endpoints

Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
24 - 48 hours after completion of the procedure
Blood Concentrations of Propofol
At the end of the initiation period and every 2 minutes during the maintenance period
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm1 - PlaceboPLACEBO_COMPARATOR -
Arm 2 - ICI35,868 (propofol)ACTIVE_COMPARATOR -
Arm 3 - ICI35,868 (propofol)ACTIVE_COMPARATOR -
Arm 4 - ICI35,868 (propofol)ACTIVE_COMPARATOR -
Arm 5 - ICI35,868 (propofol)ACTIVE_COMPARATOR -
Arm 6 - ICI35,868 (propofol)ACTIVE_COMPARATOR -
Arm 7 - ICI35,868 (propofol)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGInfusion of placebo, same infusion rates as for arm 2
ICI35,868 (propofol)DRUGInfusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female (females of child bearing potential to confirm not pregnant via test or contraception) * Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour Exclusion Criteria: * American So...

Countries:Japan
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Frequently asked questions about ICI35, 868

What is ICI35,868 used for?

ICI35,868 is an investigational small molecule being developed for use in gastrointestinal endoscopy, including procedures such as gastrointestinal polypectomy. It is intended to provide sedation for patients undergoing upper and lower endoscopic tests. The drug is currently in Phase 2 clinical development.

Who is developing ICI35,868?

ICI35,868 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for gastrointestinal endoscopy indications.

What phase is ICI35,868 in?

ICI35,868 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed, involving 123 participants.

What clinical trials is ICI35,868 in?

ICI35,868 has one completed Phase 2 clinical trial registered under NCT01189604. The trial was a dose rate range finding study of propofol for minimal-to-moderate sedation during upper and lower endoscopic tests, conducted in Japan with 123 participants.

Is ICI35,868 the same as propofol?

ICI35,868 is being studied in a clinical trial that evaluates propofol for sedation during endoscopic procedures. The trial title references propofol, and ICI35,868 may be the investigational name for this drug in the context of this study.