An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00261599

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to help them relax and stay calm during the procedure. This is called procedural or minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN (fospropofol disodium) is made as a water soluble form of propofol allowing for rapid sedation during the entire procedure. This study is designed to test AQUAVAN for sedation during colonoscopy procedures.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: AQUAVAN® (fospropofol disodium) Injection Drug: Midazolam HCI	Phase 3

Detailed Description

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of a moderate dose of AQUAVAN compared to a subtherapeutic dose of AQUAVAN,both following pretreatment with an analgesic fentanyl, in patients who are undergoing elective 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 3 treatment groups at a 2:3:1 (AQUAVAN initial dose 1 [subtherapeutic dose]:AQUAVAN initial dose 2 [moderate dose]: initial Midazolam Reference Dose) allocation ratio on the day of the scheduled procedure.

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 an ECG monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of study medication. All patients will receive an injection of analgesic pretreatment followed by the administration of study medication. This protocol recognized 2 distinct phases of sedation: Sedation Initiation and Sedation Maintenance. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit of sedation, and adverse events. Blood samples will be collected for PK analysis.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double-Blind, Dose-Controlled Study to Assess the Efficacy and Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal to Moderate Sedation in Patients Undergoing Colonoscopy

Study Start Date :

Mar 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Sedation Success - 3 consecutive modified OAA/S scores of ≤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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Number of patients/site: Approximately 300 patients at up to 30 sites will be randomized into this study.
Study Country Location: United States

Inclusion Criteria:

Patient must be able to understand required assessments and procedures.
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 must have 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, opioid, or benzodiazepine.
Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
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 3-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 postprocedural instructions.
Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Patient for whom the use of midazolam HCl injection (midazolam) is contraindicated.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Associates	Huntsville	Alabama	United States	35801
2	UCSF-Fresno/University Medical Center	Fresno	California	United States	93702
3	Borland-Groover Clinic	Jacksonville	Florida	United States	32256
4	Rockford Gastroenterology Associates	Rockford	Illinois	United States	61107
5	Welborn Clinic	Evansville	Indiana	United States	47713
6	Indiana University Medical Center/Clarian Health Partner	Indianapolis	Indiana	United States	46202
7	Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
8	Maryland Digestive Diseases Center	Laurel	Maryland	United States	20707
9	Shah Associates	Prince Frederick	Maryland	United States	20678
10	Oakland Colon & Rectal Associates	Royal Oak	Michigan	United States	48067
11	Center for Digestive Health	Troy	Michigan	United States	48098
12	Gastrointestinal Associates, PA	Jackson	Mississippi	United States	39202
13	Research Associates of New York (New York Gastroenterology Associates)	New York	New York	United States	10021
14	Asheville Gastroenterology Associates	Asheville	North Carolina	United States	28801
15	WestHills Gastroenterology Associates	Portland	Oregon	United States	97225
16	Memphis Gastroenterology Group, PC	Germantown	Tennessee	United States	38138
17	Gastrointestinal Institute	Nashville	Tennessee	United States	37203
18	Alamo Research Center	San Antonio	Texas	United States	78215
19	Spokane Digestive Disease Center	Spokane	Washington	United States	99204
20	Wisconsin Center for Advance Research	Milwaukee	Wisconsin	United States	53215