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
NCT ID: NCT01127438
Last Updated: 2013-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
153 participants
INTERVENTIONAL
2010-04-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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fospropofol disodium Subgroup 1 Lower Dose
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)
: fospropofol disodium Subgroup 1 Approved Dose
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)
fospropofol disodium Subgroup 2 Lower Dose
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
fospropofol disodium Subgroup 2 Approved Dose
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
fospropofol disodium Subgroup 3 Lower Dose
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
fospropofol disodium Subgroup 3 Approved Dose
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
Interventions
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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)
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)
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
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
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
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
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jim Ferry
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Southern California Permanente Medical Group
Baldwin Park, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Center for Advanced Gastroenterology
Maitland, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Sheridan Clinical Research
Sunrise, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Research Associates of New York, LLP
New York, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University Medical Center Department of Anesthesiology
Columbus, Ohio, United States
Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital
Tyrone, Pennsylvania, United States
Ilumina Clinical Associates
Uniontown, Pennsylvania, United States
Digestive Health Associates
Plano, Texas, United States
Clinical Trial Network
Spring, Texas, United States
Utah Digestive Health Institute
Clinton, Utah, United States
Northern Utah Gastroenterology
Logan, Utah, United States
Advance Clinical Research
Odgen, Utah, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Countries
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Other Identifiers
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E2083-A001-406
Identifier Type: -
Identifier Source: org_study_id
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