A Study to Assess the Efficacy and Safety of Fospropofol Disodium

January 5, 2011 updated by: West China Hospital

A Phase 1,Open, Dose-escalation Study to Assess the Efficacy and Safety of Fospropofol Disodium Injection in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: In the treatment arm
Drug: Fospropofol disodium
Fospropofol disodium： 0.5g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BIS
Time Frame: 2hr after administration
2hr after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified OAA/S Score
Time Frame: 2hr after administration
2hr after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Chair: Jin Liu, MD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFDA2009L09746
  • 2009L09746 (Other Identifier: the State Food and Drug Administration in China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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