Status:
TERMINATED
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
PPD Development, LP
Covance
Conditions:
Colonoscopy
Colon Polyps
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in elderly patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus th...
Detailed Description
This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN ® Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate injection, in p...
Eligibility Criteria
Inclusion
- Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
- Patient was over 65 years of age at the time of screening.
- Patient met ASA Physical Status Classification of I to III.
Exclusion
- Patient had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
- Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
- Patient had condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
- Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
- Patient was unwilling to adhere to pre- and postprocedural instructions.
- The use of fentanyl or midazolam was contraindicated for the patient.
- Patient had participated in an investigational drug study within 1 month prior to study start.
- Patient had prior exposure to AQUAVAN.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00209599
Start Date
February 1 2005
End Date
March 1 2005
Last Update
June 18 2023
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