Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
NCT ID: NCT01961349
Last Updated: 2015-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
279 participants
INTERVENTIONAL
2013-10-31
2014-03-31
Brief Summary
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The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Group 1 (placebo group) is treated by Anaesthesiologist
Intralipid
Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
Group 2
Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
ICI35,868 (Diprivan)
Treated by Anaesthesiologist
Group 3
Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
ICI35,868 (Diprivan) + EES0000645/A (SDS)
Treated by Endoscopist with EES0000645/A(SDS)
Interventions
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Intralipid
Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
ICI35,868 (Diprivan)
Treated by Anaesthesiologist
ICI35,868 (Diprivan) + EES0000645/A (SDS)
Treated by Endoscopist with EES0000645/A(SDS)
Eligibility Criteria
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Exclusion Criteria
2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
4. Baseline (Visit 1) of blood oxygen saturation (SpO2)\<90% (room air)
5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.
20 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Moriya-shi, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Yokohama, , Japan
Countries
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Related Links
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D0092C00002\_CSR\_Synopsis.pdf
Other Identifiers
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D0092C00002
Identifier Type: -
Identifier Source: org_study_id