Status:
COMPLETED
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Johnson & Johnson K.K. Medical Company
Conditions:
Gastrointestinal Endoscopy
Gastrointestinal Polypectomy
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
Eligibility Criteria
Inclusion
- Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
- Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour
Exclusion
- American Society of Anesthesiologists (ASA) grade III, IV V and VI
- Baseline oxygen saturation\<90% (room air)
- Body Mass Index (BMI) \>=35
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01189604
Start Date
August 1 2010
End Date
November 1 2010
Last Update
December 19 2011
Active Locations (2)
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1
Research Site
Isesaki, Gunma, Japan
2
Research Site
Moriya, Ibaragi, Japan