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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

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ClinicalTrials.gov Identifier: NCT01309984
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Lactating Women Drug: Lusedra Drug: Propofol Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: arm 1 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)
Active Comparator: arm 2 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)



Primary Outcome Measures :
  1. Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours. [ Time Frame: 24 hours ]
  2. Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours [ Time Frame: 24 hours ]
  3. The fraction (%) of the maternal dose transferred to breast milk in 24 hours [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309984


Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Christa Nagy Eisai Inc.

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01309984     History of Changes
Other Study ID Numbers: E2083-A001-405
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Eisai Inc.:
Monitored anesthesia care

Additional relevant MeSH terms:
Propofol
Fospropofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics