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

Conscious Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261599
• Other study ID #: 3000-0522
• Secondary ID: MGI 3000-0522
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2005
• Last updated: November 6, 2008
• Start date: March 2006
• Est. completion date: October 2006

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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:

1. Patient must be able to understand required assessments and procedures.

2. 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.

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

4. 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.

5. 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, opioid, or benzodiazepine.

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

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 3-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 postprocedural instructions.

7. Patient for whom the use of fentanyl citrate injection (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

• Conscious Sedation

Intervention

Drug:
• AQUAVAN® (fospropofol disodium) Injection

• Midazolam HCI

Locations

Country	Name	City	State
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Welborn Clinic	Evansville	Indiana
United States	UCSF-Fresno/University Medical Center	Fresno	California
United States	Memphis Gastroenterology Group, PC	Germantown	Tennessee
United States	Clinical Research Associates	Huntsville	Alabama
United States	Indiana University Medical Center/Clarian Health Partner	Indianapolis	Indiana
United States	Gastrointestinal Associates, PA	Jackson	Mississippi
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Maryland Digestive Diseases Center	Laurel	Maryland
United States	Wisconsin Center for Advance Research	Milwaukee	Wisconsin
United States	Gastrointestinal Institute	Nashville	Tennessee
United States	Research Associates of New York (New York Gastroenterology Associates)	New York	New York
United States	WestHills Gastroenterology Associates	Portland	Oregon
United States	Shah Associates	Prince Frederick	Maryland
United States	Rockford Gastroenterology Associates	Rockford	Illinois
United States	Oakland Colon & Rectal Associates	Royal Oak	Michigan
United States	Alamo Research Center	San Antonio	Texas
United States	Spokane Digestive Disease Center	Spokane	Washington
United States	Center for Digestive Health	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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