Status:
COMPLETED
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
PPD Development, LP
Bio Analytical Research Corporation
Conditions:
Colonoscopy
Colon Polyps
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of mi...
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 pr...
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, if female, were surgically sterile, postmenopausal or non-pregnant and non lactating using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose periods; and
- Patient met American Society of Anesthesiologists (ASA) Physical Status Classification System 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 participated in an investigational drug study within 1 month prior to study start;
- 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; or
- Patient for whom the use of fentanyl or midazolam was contraindicated.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00209573
Start Date
September 1 2004
End Date
December 1 2004
Last Update
November 7 2008
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