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Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

Primary Purpose

Colonoscopy, Colonic Polyps

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AQUAVAN® (fospropofol disodium) Injection
Midazolam HCl
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy focused on measuring Colonoscopy, Sedation, AQUAVAN, (fospropofol disodium), Endoscopic sedation, Endoscopic outcomes, Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

- Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites will be randomized into this study. - Study Country Location: United States - Study Population: Male and female patients aged 18 years and older and undergoing elective colonoscopy will be enrolled in the study. Inclusion Criteria: Patient provides signed/dated informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study Patient must be at least 18 years of age at the time of screening If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and has been 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 pre-dose Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4 Exclusion Criteria: Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines Patient has a Mallampati classification score of 4; OR a Mallampati classification score of 3 AND a thyromental distance <= 4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator Patient has an abnormal, clinically significant 12-lead ECG finding at predosing period Day 0 Patient has participated in an investigational drug study within 1 month prior to study start Patient is unwilling to adhere to pre- and post-procedural instructions Patient for whom the use of fentanyl is contraindicated Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated

Sites / Locations

  • Clinical Research Associates
  • Arizona Research Center
  • Atlanta Gastroenterology Associates
  • Rockford Gastroenterology Associates Ltd.
  • Welborn Clinic
  • Gulf Coast Research Associates, Inc.
  • Gastroenterology Clinic
  • Chevy Chase Clinical Research
  • Endoscopic Microsurgery Associates, PA
  • Gastrointestinal Associates, PA
  • Winthrop-University Hospital
  • Research Associates of New York
  • Asheville Gastroenterology Associates/The Endoscopy Center
  • Oklahoma Gastroenterology Associates
  • Memphis Gastroenterology Group, PC
  • Gastrointestinal Institute
  • St. Thomas Medical Group, P.C.
  • Alamo Research Center
  • Spokane Digestive Diseases Center
  • Wisconsin Center for Advance Research

Outcomes

Primary Outcome Measures

Three consecutive MOAA/S scores ≤4 after administration of sedative medication AND completing the procedure without requiring the use of alternative sedative medication AND without requiring manual or mechanical ventilation

Secondary Outcome Measures

Patient's rating of experience after ready for discharge
Principal Investigator's (PI's) rating at end of procedure
Percentage of patients requiring alternative sedative medication
Number of doses/amount of fentanyl administered
Number of doses of study medication administered
Time to sedation, digital rectal examination, start of procedure, reach splenic flexure, hepatic flexure, cecum, end of procedure, and ready for discharge
Percentage of patients requiring repositioning
Percentage of patients whose procedures are interrupted due to inadequate sedation
Time to ready for discharge from end of procedure
Change from baseline DSST score over time during recovery period
Patient's rating at 24 hour post discharge telephone survey
Duration and percent of time when a patient's MOAA/S score is at each level between the first dose of study medications and fully alert and during the procedure
PI's rating of level of sedation prior to initiation of the procedure
Percentage of patients with a mean MOAA/S of 2 to 4 and 0 to 1 during the procedure
MOAA/S over time

Full Information

First Posted
July 27, 2005
Last Updated
November 6, 2008
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00125424
Brief Title
Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Official Title
A Randomized, Double-Blind, Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN® Injection for Procedural Sedation in Patients Undergoing Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol, allowing for fast sedation and possibly faster recovery and discharge. This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.
Detailed Description
This is a randomized, double-blind study designed to evaluate the dose-response in the sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients undergoing a colonoscopy. A group of patients will receive midazolam as a reference therapy. Following completion of pre-procedure assessments, patients will be randomly assigned to 1 of 5 IV treatment groups at an equal allocation ratio (25 patients per arm) on the day of the scheduled procedure. Randomization will be stratified by age and ASA status: AQUAVAN initial bolus dose 1: 8 mg/kg AQUAVAN initial bolus dose 2: 6.5 mg/kg AQUAVAN initial bolus dose 3: 5 mg/kg AQUAVAN initial bolus dose 4: 2 mg/kg Midazolam initial bolus dose: 0.02 mg/kg A person skilled in airway management and authorized by the facility in which the colonoscopy is performed (such as a respiratory therapist, a study nurse, or a clinician) must be immediately available during the conduct of the study. All patients will be placed on supplemental oxygen via nasal cannula (4 L/min), and a 12-lead electrocardiogram (ECG), pulse oximeter, and blood pressure monitor prior to administration of study medication. All patients will receive an injection of analgesic pretreatment followed by the administration of sedative medication, as described below. This protocol recognizes 2 distinct phases of sedation: Sedation Initiation and Sedation Maintenance. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit, and adverse events as detailed in the protocol. Blood samples will be collected for pharmacokinetic (PK) analysis, also detailed in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colonic Polyps
Keywords
Colonoscopy, Sedation, AQUAVAN, (fospropofol disodium), Endoscopic sedation, Endoscopic outcomes, Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
125 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AQUAVAN® (fospropofol disodium) Injection
Intervention Type
Drug
Intervention Name(s)
Midazolam HCl
Primary Outcome Measure Information:
Title
Three consecutive MOAA/S scores ≤4 after administration of sedative medication AND completing the procedure without requiring the use of alternative sedative medication AND without requiring manual or mechanical ventilation
Secondary Outcome Measure Information:
Title
Patient's rating of experience after ready for discharge
Title
Principal Investigator's (PI's) rating at end of procedure
Title
Percentage of patients requiring alternative sedative medication
Title
Number of doses/amount of fentanyl administered
Title
Number of doses of study medication administered
Title
Time to sedation, digital rectal examination, start of procedure, reach splenic flexure, hepatic flexure, cecum, end of procedure, and ready for discharge
Title
Percentage of patients requiring repositioning
Title
Percentage of patients whose procedures are interrupted due to inadequate sedation
Title
Time to ready for discharge from end of procedure
Title
Change from baseline DSST score over time during recovery period
Title
Patient's rating at 24 hour post discharge telephone survey
Title
Duration and percent of time when a patient's MOAA/S score is at each level between the first dose of study medications and fully alert and during the procedure
Title
PI's rating of level of sedation prior to initiation of the procedure
Title
Percentage of patients with a mean MOAA/S of 2 to 4 and 0 to 1 during the procedure
Title
MOAA/S over time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites will be randomized into this study. - Study Country Location: United States - Study Population: Male and female patients aged 18 years and older and undergoing elective colonoscopy will be enrolled in the study. Inclusion Criteria: Patient provides signed/dated informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study Patient must be at least 18 years of age at the time of screening If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and has been 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 pre-dose Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4 Exclusion Criteria: Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines Patient has a Mallampati classification score of 4; OR a Mallampati classification score of 3 AND a thyromental distance <= 4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator Patient has an abnormal, clinically significant 12-lead ECG finding at predosing period Day 0 Patient has participated in an investigational drug study within 1 month prior to study start Patient is unwilling to adhere to pre- and post-procedural instructions Patient for whom the use of fentanyl is contraindicated Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Jones, PharmD, MD
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rockford Gastroenterology Associates Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Gulf Coast Research Associates, Inc.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Gastroenterology Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Endoscopic Microsurgery Associates, PA
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Winthrop-University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Research Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates/The Endoscopy Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Oklahoma Gastroenterology Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Memphis Gastroenterology Group, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Gastrointestinal Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
St. Thomas Medical Group, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Alamo Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Spokane Digestive Diseases Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Wisconsin Center for Advance Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

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