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

February 6, 2013 updated by: Eisai Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Sedation Success
Time Frame: Day 1
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Success
Time Frame: Day 1
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
Time Frame: Day 1
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jim Ferry, Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2083-A001-406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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