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

NCT01127438 | Completed Phase 4 Results

• 1 other identifier: E2083-A001-406
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 23

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.

Conditions

Sedation

Keywords

Monitored anesthesia care sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Treatment Success

  Day 1

• Number of Participants With Modified Sedation Success

  Day 1

Study Arms (6)

fospropofol disodium Subgroup 1 Lower Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 1 Lower Dose

: fospropofol disodium Subgroup 1 Approved Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 1 Approved Dose

fospropofol disodium Subgroup 2 Lower Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 2 Lower Dose

fospropofol disodium Subgroup 2 Approved Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 2 Approved Dose

fospropofol disodium Subgroup 3 Lower Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 3 Lower Dose

fospropofol disodium Subgroup 3 Approved Dose

ACTIVE COMPARATOR

Drug: fospropofol disodium Subgroup 3 Approved Dose

Interventions

fospropofol disodium Subgroup 1 Lower Dose DRUG

Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight \< 60 kg and Age \< 65 years and ASAI and II)

fospropofol disodium Subgroup 1 Lower Dose

fospropofol disodium Subgroup 1 Approved Dose DRUG

(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight \<60 kg and Age \<65 years and ASAI and II)

: fospropofol disodium Subgroup 1 Approved Dose

fospropofol disodium Subgroup 2 Lower Dose DRUG

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

fospropofol disodium Subgroup 2 Lower Dose

fospropofol disodium Subgroup 2 Approved Dose DRUG

(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight \<60 kg and Age \>/=65 years and ASA 3 or 4

fospropofol disodium Subgroup 2 Approved Dose

fospropofol disodium Subgroup 3 Lower Dose DRUG

(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

fospropofol disodium Subgroup 3 Lower Dose

fospropofol disodium Subgroup 3 Approved Dose DRUG

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

fospropofol disodium Subgroup 3 Approved Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (23)

Hope Research Institute

Phoenix, Arizona, 85050, United States

Location

Southern California Permanente Medical Group

Baldwin Park, California, 91706, United States

Location

Desta Digestive Disease Medical Center

San Diego, California, 92114, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Center for Advanced Gastroenterology

Maitland, Florida, 32751, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Sheridan Clinical Research

Sunrise, Florida, 33323, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Research Associates of New York, LLP

New York, New York, 10075, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center Department of Anesthesiology

Columbus, Ohio, 43210, United States

Location

Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital

Tyrone, Pennsylvania, 16686, United States

Location

Ilumina Clinical Associates

Uniontown, Pennsylvania, 15401, United States

Location

Digestive Health Associates

Plano, Texas, 75075, United States

Location

Clinical Trial Network

Spring, Texas, 77386, United States

Location

Utah Digestive Health Institute

Clinton, Utah, 84015, United States

Location

Northern Utah Gastroenterology

Logan, Utah, 84341-2534, United States

Location

Advance Clinical Research

Odgen, Utah, 84405, United States

Location

Utah Clinical Trials, LLC

Salt Lake City, Utah, 84107, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Jim Ferry

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 8, 2013
• Results First Posted: February 8, 2013

Record last verified: 2013-02

Locations

US (23)