Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy; Gastrointestinal Polypectomy
• Intervention / Treatment: Drug: Placebo; Drug: ICI35,868 (propofol); Drug: ICI35,868 (propofol); Drug: ICI35,868 (propofol); Drug: ICI35,868 (propofol); Drug: ICI35,868 (propofol); Drug: ICI35,868 (propofol)

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Gunma
    • Isesaki, Gunma, Japan
      • Research Site
  • Ibaragi
    • Moriya, Ibaragi, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Society of Anesthesiologists (ASA) grade III, IV V and VI
• Baseline oxygen saturation<90% (room air)
• Body Mass Index (BMI) >=35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm1 - Placebo	Drug: Placebo; Infusion of placebo, same infusion rates as for arm 2
Active Comparator: Arm 2 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Active Comparator: Arm 3 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Active Comparator: Arm 4 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Active Comparator: Arm 5 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Active Comparator: Arm 6 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
Active Comparator: Arm 7 - ICI35,868 (propofol)	Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute; Drug: ICI35,868 (propofol); Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of 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.	2 minutes from the beginning of the maintenance period
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of 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.	4 minutes from the beginning of the maintenance period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire	The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).	24 - 48 hours after completion of the procedure
Blood Concentrations of Propofol	Blood concentration of ICI35,868 (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	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.	Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Johnson & Johnson K.K. Medical Company
• Investigators: Study Director: Masataka Date, M.D., Ph.D., Physician Group, Clinical Division, R&D, Astrazeneca K.K.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 19, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: propofol endoscopy sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: D0092C00001