A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.

Study Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Drug: fospropofol disodium Subgroup 1 Lower Dose; Drug: fospropofol disodium Subgroup 1 Approved Dose; Drug: fospropofol disodium Subgroup 2 Lower Dose; Drug: fospropofol disodium Subgroup 2 Approved Dose; Drug: fospropofol disodium Subgroup 3 Lower Dose; Drug: fospropofol disodium Subgroup 3 Approved Dose

Detailed Description

This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • HOPE Research Institute
  • California
    • Baldwin Park, California, United States, 91706
      • Southern California Permanente Medical Group
    • San Diego, California, United States, 92114
      • Desta Digestive Disease Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Maitland, Florida, United States, 32751
      • Center for Advanced Gastroenterology
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • Sunrise, Florida, United States, 33323
      • Sheridan Clinical Research
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia, PC
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center
  • New York
    • New York, New York, United States, 10075
      • Research Associates of New York, LLP
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center Department of Anesthesiology
  • Pennsylvania
    • Tyrone, Pennsylvania, United States, 16686
      • Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital
    • Uniontown, Pennsylvania, United States, 15401
      • Ilumina Clinical Associates
  • Texas
    • Plano, Texas, United States, 75075
      • Digestive Health Associates
    • Spring, Texas, United States, 77386
      • Clinical Trial Network
  • Utah
    • Clinton, Utah, United States, 84015
      • Utah Digestive Health Institute
    • Logan, Utah, United States, 84341-2534
      • Northern Utah Gastroenterology
    • Odgen, Utah, United States, 84405
      • Advance Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Utah Clinical Trials, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Fairfax, Virginia, United States, 22031
      • Gastroenterology Associates of Northern Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Subjects who meet all of the following criteria will be included in the study:

1. Male and female adult candidates for diagnostic or therapeutic colonoscopy with at least one of the following characteristics:

   • Subgroup 1: Weight < 60 kg and age >/= 18 to < 65 years and ASA I or II;
   • Subgroup 2: Weight < 60 kg and age >/= 65 years and/or ASA 3 or 4; or
   • Subgroup 3: Weight >/=60 kg and age >/= 65 years and/or ASA 3 or 4.
2. Females of childbearing potential must have a negative beta human chorionic gonadotropin (?hCG) urine pregnancy test at Visit 1 (Screening) and prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device [IUD], or have a vasectomised partner) having starting for at least 1 menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential;
3. Are willing and able to comply with all aspects of the protocol; and
4. Provide written informed consent.

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Females who are pregnant (positive BhCG urine pregnancy test) or breastfeeding;
2. Subjects who do not meet nil per os (NPO) requirement of no solid foods within 8 hours and clear fluids up to 3 hours before the procedure (assessed only at Baseline);
3. Evidence of clinically significant disease or a history of a concomitant medical condition (eg, cardiac, respiratory, gastrointestinal, renal disease) that, in the opinion of the Investigator, could affect the subject's safety or ability to safely complete the study;
4. Subjects with hypersensitivity to LUSEDRA or any other components of LUSEDRA, including its active metabolite, propofol;
5. History of drug or alcohol dependency or abuse within approximately the last 2 years; or
6. The Investigator believes to be medically unfit to receive the study drug or unsuitable for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: fospropofol disodium Subgroup 1 Lower Dose	Drug: fospropofol disodium Subgroup 1 Lower Dose; Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II)
ACTIVE_COMPARATOR: : fospropofol disodium Subgroup 1 Approved Dose	Drug: fospropofol disodium Subgroup 1 Approved Dose; (Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II)
ACTIVE_COMPARATOR: fospropofol disodium Subgroup 2 Lower Dose	Drug: fospropofol disodium Subgroup 2 Lower Dose; Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4
ACTIVE_COMPARATOR: fospropofol disodium Subgroup 2 Approved Dose	Drug: fospropofol disodium Subgroup 2 Approved Dose; (Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4
ACTIVE_COMPARATOR: fospropofol disodium Subgroup 3 Lower Dose	Drug: fospropofol disodium Subgroup 3 Lower Dose; (Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4
ACTIVE_COMPARATOR: fospropofol disodium Subgroup 3 Approved Dose	Drug: fospropofol disodium Subgroup 3 Approved Dose; Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Sedation Success	Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Success	Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.	Day 1
Number of Participants With Modified Sedation Success	Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.	Day 1

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Jim Ferry, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (ESTIMATE): May 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Monitored anesthesia care sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Fospropofol
• Other Study ID Numbers: E2083-A001-406