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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125424
• Other study ID #: 3000-0520
• Secondary ID: GPI 3000-0520
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 27, 2005
• Last updated: November 6, 2008
• Start date: July 2005
• Est. completion date: September 2005

Study information

• Verified date: November 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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:

1. 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

2. Patient must be at least 18 years of age at the time of screening

3. 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

4. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4

Exclusion Criteria:

1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine

2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines

3. 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

4. Patient has an abnormal, clinically significant 12-lead ECG finding at predosing period Day 0

5. Patient has participated in an investigational drug study within 1 month prior to study start

6. Patient is unwilling to adhere to pre- and post-procedural instructions

7. Patient for whom the use of fentanyl is contraindicated

8. Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Polyps
• Colonoscopy

Intervention

Drug:
• AQUAVAN® (fospropofol disodium) Injection

• Midazolam HCl

Locations

Country	Name	City	State
United States	Asheville Gastroenterology Associates/The Endoscopy Center	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Gulf Coast Research Associates, Inc.	Baton Rouge	Louisiana
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Welborn Clinic	Evansville	Indiana
United States	Clinical Research Associates	Huntsville	Alabama
United States	Gastrointestinal Associates, PA	Jackson	Mississippi
United States	Memphis Gastroenterology Group, PC	Memphis	Tennessee
United States	Wisconsin Center for Advance Research	Milwaukee	Wisconsin
United States	Winthrop-University Hospital	Mineola	New York
United States	Gastroenterology Clinic	Monroe	Louisiana
United States	Gastrointestinal Institute	Nashville	Tennessee
United States	St. Thomas Medical Group, P.C.	Nashville	Tennessee
United States	Research Associates of New York	New York	New York
United States	Arizona Research Center	Phoenix	Arizona
United States	Rockford Gastroenterology Associates Ltd.	Rockford	Illinois
United States	Alamo Research Center	San Antonio	Texas
United States	Spokane Digestive Diseases Center	Spokane	Washington
United States	Endoscopic Microsurgery Associates, PA	Towson	Maryland
United States	Oklahoma Gastroenterology Associates	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

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