A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 21, 2005
Last Update Posted Date	December 4, 2009
Study Start Date ICMJE	January 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 6, 2008)	The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients.
Original Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S ³2 and £4) in a majority of patients.
Change History	Complete list of historical versions of study NCT00209534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 13, 2005)	Efficacy variables included: time to sedation, time to Fully Alert, time to Fully Recovered, time to Ready for Discharge, Modified OAA/S scores over time, number of doses and amount of AQUAVAN, and Patient and Physician Satisfaction Surveys.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Official Title ICMJE	A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
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 citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
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 level in patients undergoing elective colonoscopy. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in a majority of patients who are pre-medicated with fentanyl citrate injection.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Colonoscopy; Colon Polyps
Intervention ICMJE	Drug: fospropofol disodium
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 13, 2005)	200
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	February 2004
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00209534
Other Study ID Numbers ICMJE	3000-0207
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Eisai Inc.
Collaborators ICMJE	Omnicare Clinical Research; Bio Analytical Research Corporation; MDS Pharma Services; The Coghlan Group (Plasma Sample Supplies); HHI Clinical Research (Biostatistics)
Investigators ICMJE	Study Director: James Jones, MD,PharmD Eisai Inc.
PRS Account	Eisai Inc.
Verification Date	December 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP