A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT01309984

First received: March 2, 2011

Last updated: February 1, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2011

Last Updated Date

February 1, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
The fraction (%) of the maternal dose transferred to breast milk in 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01309984 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

Official Title ^ICMJE

An Open-label, Single Initial-dose, Multi-center Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

Brief Summary

The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.

Detailed Description

E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.1 It is a water-soluble, phosphono-O-methyl prodrug of propofol. Upon IV injection, the inactive fospropofol undergoes metabolism, most notably by alkaline phosphatase enzymes, to yield the active metabolite (propofol), phosphate, and formaldehyde. Formaldehyde is quickly converted to formate in vivo, and formate is further metabolized by a folate-dependent mechanism.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lactating Women

Intervention ^ICMJE

Drug: Lusedra
Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)
Drug: Propofol
Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)

Study Arm (s)

Active Comparator: arm 1
Intervention: Drug: Lusedra
Active Comparator: arm 2
Intervention: Drug: Propofol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusions:

Lactating women undergoing a needed procedure expected to last between approximately 10 to 45 minutes
Subjects should be between 6 weeks and 8 months postpartum
Lactation must be well-established in subjects
Subject's infants must be full term and able to bottle-feed
Infants should be predominantly breast milk fed and should not receive more than one bottle of formula per day

Exclusions:

Subjects who are pregnant
Subjects undergoing a breast procedure (eg, biopsy, abscess drainage, etc.)
Subjects who are not willing to temporarily refrain from nursing their children during the 0-24 hour breast milk collection interval.

(Subjects may resume nursing following this interval).

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01309984

Other Study ID Numbers ^ICMJE

E2083-A001-405

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc.

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christa Nagy

Eisai Inc.

Information Provided By

Eisai Inc.

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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