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
- Conditions
- Sedation
- Interventions
- Registration Number
- NCT01127438
- Lead Sponsor
- Eisai Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fospropofol disodium Subgroup 2 Lower Dose fospropofol disodium Subgroup 2 Lower Dose - fospropofol disodium Subgroup 2 Approved Dose fospropofol disodium Subgroup 2 Approved Dose - fospropofol disodium Subgroup 1 Lower Dose fospropofol disodium Subgroup 1 Lower Dose - : fospropofol disodium Subgroup 1 Approved Dose fospropofol disodium Subgroup 1 Approved Dose - fospropofol disodium Subgroup 3 Lower Dose fospropofol disodium Subgroup 3 Lower Dose - fospropofol disodium Subgroup 3 Approved Dose fospropofol disodium Subgroup 3 Approved Dose -
- Primary Outcome Measures
Name Time Method Number of Participants With Sedation Success 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Success 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.
Number of Participants With Modified Sedation Success 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.
Trial Locations
- Locations (23)
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Research Associates of New York, LLP
🇺🇸New York, New York, United States
Ilumina Clinical Associates
🇺🇸Uniontown, Pennsylvania, United States
Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital
🇺🇸Tyrone, Pennsylvania, United States
Clinical Trial Network
🇺🇸Spring, Texas, United States
Northern Utah Gastroenterology
🇺🇸Logan, Utah, United States
Advance Clinical Research
🇺🇸Odgen, Utah, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Southern California Permanente Medical Group
🇺🇸Baldwin Park, California, United States
Center for Advanced Gastroenterology
🇺🇸Maitland, Florida, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Sheridan Clinical Research
🇺🇸Sunrise, Florida, United States
Digestive Health Associates
🇺🇸Plano, Texas, United States
Utah Digestive Health Institute
🇺🇸Clinton, Utah, United States
Desta Digestive Disease Medical Center
🇺🇸San Diego, California, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Gastroenterology Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Ohio State University Medical Center Department of Anesthesiology
🇺🇸Columbus, Ohio, United States
Utah Clinical Trials, LLC
🇺🇸Salt Lake City, Utah, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Duke University
🇺🇸Durham, North Carolina, United States