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A Study to Assess the Efficacy and Safety of Fospropofol Disodium

This study has been completed.
Sponsor:
Information provided by:
West China Hospital
ClinicalTrials.gov Identifier:
NCT01271569
First received: January 5, 2011
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Drug Safety
 Drug: Fospropofol disodium
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1,Open, Dose-escalation Study to Assess the Efficacy and Safety of Fospropofol Disodium Injection in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • BIS [ Time Frame: 2hr after administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Modified OAA/S Score [ Time Frame: 2hr after administration ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
In the treatment arm Drug: Fospropofol disodium
Fospropofol disodium： 0.5g

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271569

Locations
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
Study Chair: Jin Liu, MD West China Hospital
  More Information

No publications provided

Responsible Party: West China Hospital, Sichuan University
ClinicalTrials.gov Identifier: NCT01271569     History of Changes
Other Study ID Numbers: SFDA2009L09746, 2009L09746
Study First Received: January 5, 2011
Last Updated: January 5, 2011
Health Authority: China: the State Food and Drug Administration

Additional relevant MeSH terms:
Fospropofol disodium
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 16, 2013