Status:
COMPLETED
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Omnicare Clinical Research
Bio Analytical Research Corporation
Conditions:
Colonoscopy
Colon Polyps
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl ci...
Detailed Description
Randomized, open label, multi-center, adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation ...
Eligibility Criteria
Inclusion
- Patients provided written informed consent after receiving a full explanation of the extent and nature of the study.
- Patients were \>=18 years of age to ≤60 years (a subset of up to 50 patients \>60 years and \<85 years of age was allowed).
- Patients, if female, were surgically sterile, postmenopausal or non-pregnant 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.
- Body mass index (BMI) between 20 and 28.
- Body weight between 50 kg and 100 kg.
- Patients had an ASA Physical Classification System status of I or II;
- Patients required an elective colonoscopy procedure that was anticipated to be performed in \<60 minutes (i.e., procedure was predicted to be uncomplicated); desired sedation for the colonoscopy procedure; and were determined by the Investigator to be physically capable of maintaining an adequate airway during mild-to-moderate sedation.
Exclusion
- Patients ingested benzodiazepines or barbiturates within 14 days of study start, with the exception of phenobarbital, which required a 21-day washout.
- Patients ingested opioids within 72 hours of study start.
- Patients had current symptoms of upper respiratory infection.
- Patients had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
- Patients had current signs of significant hiatal hernia, esophageal reflux, or heartburn which, in the opinion of the Investigator, could interfere with maintenance of an adequate airway.
- Patients had a history of alcohol or drug abuse within the past 12 months;
- Patients ingested alcohol or caffeine within 12 hours prior to admission into the study.
- Patients participated in an investigational drug study within 1 month prior to study start.
- Patients were unwilling to adhere to preprocedural and postprocedural instructions.
- Patients donated \>300 mL of blood within 1 month prior to study start; or
- Patients were exposed to AQUAVAN in a previous clinical trial.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00209534
Start Date
January 1 2003
End Date
February 1 2004
Last Update
December 4 2009
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