Clinical trial NCT01127438: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: Monitored anesthesia care sedation
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Number of Participants With Sedation Success
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Treatment Success
timeFrame: Day 1
measure: Number of Participants With Modified Sedation Success
timeFrame: Day 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Baldwin Park
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Desta Digestive Disease Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Sunrise
country: United States
facility: Sheridan Clinical Research
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: New York
country: United States
facility: Research Associates of New York, LLP
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center Department of Anesthesiology
state: Ohio
city: Tyrone
country: United States
facility: Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital
state: Pennsylvania
city: Uniontown
country: United States
facility: Ilumina Clinical Associates
state: Pennsylvania
city: Plano
country: United States
facility: Digestive Health Associates
state: Texas
city: Spring
country: United States
facility: Clinical Trial Network
state: Texas
city: Clinton
country: United States
facility: Utah Digestive Health Institute
state: Utah
city: Logan
country: United States
facility: Northern Utah Gastroenterology
state: Utah
city: Odgen
country: United States
facility: Advance Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Utah Clinical Trials, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern Virginia
state: Virginia
Study officials:
affiliation: Eisai Inc.
name: Jim Ferry
role: STUDY_DIRECTOR
References: