NCT01189604

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 13, 2011

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

August 25, 2010

Results QC Date

November 9, 2011

Last Update Submit

December 15, 2011

Conditions

Gastrointestinal EndoscopyGastrointestinal Polypectomy

Keywords

propofol endoscopy sedation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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)

Study Arms (7)

Arm1 - Placebo

PLACEBO COMPARATOR
Drug: Placebo

Arm 2 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Arm 3 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Arm 4 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Arm 5 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Arm 6 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Arm 7 - ICI35,868 (propofol)

ACTIVE COMPARATOR
Drug: ICI35,868 (propofol)

Interventions

PlaceboDRUG

Infusion of placebo, same infusion rates as for arm 2

Arm1 - Placebo
ICI35,868 (propofol)DRUG

Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute

Arm 2 - ICI35,868 (propofol)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Isesaki, Gunma, Japan

Location

Research Site

Moriya, Ibaragi, Japan

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Gerard Lynch
Organization
Astrazeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Masataka Date, M.D., Ph.D.

    Physician Group, Clinical Division, R&D, Astrazeneca K.K.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 19, 2011

Results First Posted

December 13, 2011

Record last verified: 2011-12

Locations

JP(2)