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
Condition: Sedation
Intervention: fospropofol disodium Subgroup 1 Lower Dose; fospropofol disodium Subgroup 1 Approved Dose; fospropofol disodium Subgroup 2 Lower Dose; fospropofol disodium Subgroup 2 Approved Dose; fospropofol disodium Subgroup 3 Lower Dose; fospropofol disodium Subgroup 3 Approved Dose
Intervention description: Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II); (Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II); 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; (Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4; (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; 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
Intervention MeSH terms: Fospropofol; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Monitored anesthesia care sedation

Summary:

      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.
    

Eligibility criteria:

        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.