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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01309984
First received: March 2, 2011
Last updated: January 28, 2014
Last verified: January 2014

March 2, 2011
January 28, 2014
November 2010
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01309984 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lactating Women
  • 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)
  • Active Comparator: arm 1
    Intervention: Drug: Lusedra
  • Active Comparator: arm 2
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2012
October 2012   (final data collection date for primary outcome measure)

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).

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309984
E2083-A001-405
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Christa Nagy Eisai Inc.
Eisai Inc.
January 2014

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