NCT01271569

Brief Summary

The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \[BIS\]) and to compare the dynamic properties of PropofolF to those of Propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
Last Updated

January 6, 2011

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

January 5, 2011

Last Update Submit

January 5, 2011

Conditions

Drug Safety

Outcome Measures

Primary Outcomes (1)

  • BIS

    2hr after administration

Secondary Outcomes (1)

  • Modified OAA/S Score

    2hr after administration

Study Arms (1)

In the treatment arm

OTHER
Drug: Fospropofol disodium

Interventions

Fospropofol disodiumDRUG

Fospropofol disodium： 0.5g

In the treatment arm

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

fospropofol

Study Officials

  • Jin Liu, MD

    West China Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

January 1, 2011

Last Updated

January 6, 2011

Record last verified: 2010-03

Locations

CN(1)