A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures

This study has been terminated.

Sponsor:

Collaborators:

PPD

Covance

Information provided by:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00209560

First received: September 13, 2005

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Results First Received: March 1, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Arthroscopy Bunionectomy Osteotomy Carpal Tunnel
Intervention:	Drug: fospropofol disodium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study recruited at 18 centers in the US during the period of 29-Oct-2004 to 24 Mar 2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment and before randomization all subjects, irrespective of treatment group assignment,received fentanyl citrate injection 0.5 µg/kg to 1 µg/kg(based on age)as an analgesic pretreatment 5 minutes prior to the administration of either fospropofol disodium (Also known as,LUSEDRA and formerly known as AQUAVAN) or midazolam midazolam HCl).

Reporting Groups

	Description
Fospropofol Disodium	525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
Midazolam	0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.

Participant Flow: Overall Study

	Fospropofol Disodium	Midazolam
STARTED	121	42
COMPLETED	120	42
NOT COMPLETED	1	0
Lack of Efficacy	1	0

Baseline Characteristics

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Reporting Groups

	Description
Fospropofol Disodium	525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
Midazolam	0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
Total	Total of all reporting groups

Baseline Measures

	Fospropofol Disodium	Midazolam	Total
Number of Participants [units: participants]	121	42	163
Age [units: years] Mean ± Standard Deviation	45.3 ± 11.0	45.3 ± 11.5	45.3 ± 11.1
Gender [units: participants]
Female	84	24	108
Male	37	18	55
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	14	3	17
Other	0	1	1
Unknown or Not Reported	0	0	0
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	19	10	29
White	87	28	115
More than one race	0	0	0
Weight (kg) [units: particpants]
<55	7	0	7
55 to > 80	41	14	55
>80	73	28	101
American Society of Anesthesiologists Status (ASA) [units: particpants]
I (A normal healthy patient)	48	19	67
II (A patient with mild systemic disease)	71	21	92
III (A patient with severe systemic disease)	2	2	4
History of Adverse Reactions following a Previous Sedation [units: participants]
Yes	3	2	5
No	111	37	148
No history of sedation	7	3	10

Outcome Measures

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1. Primary:

Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation [ Time Frame: Sedation success was assessed at 2 minute intervals until the end of the procedure ]

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2. Secondary:

Time to Fully Alert From the End of the Procedure [ Time Frame: At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Analysis of results from a previous fospropofol study (3000-0410) completed during the enrollment of this study indicated that the dosing regimen needed to be re-evaluated. The study was prematurely terminated after 168 subjects were randomized.

Results Point of Contact:

Name/Title: Eisai Medical Services
Organization: Eisai Inc
phone: 1-888-422-4743

No publications provided

Responsible Party:	Eisai Medical Services, Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00209560 History of Changes
Other Study ID Numbers:	3000-0412
Study First Received:	September 13, 2005
Results First Received:	March 1, 2012
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

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