An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy - Full Text View

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00306722

Purpose

Very often patients receive 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 with a longer duration of effect.

Condition	Intervention	Phase
Bronchoscopy Anesthesia	Drug: AQUAVAN® (fospropofol disodium) Injection	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Flexible Bronchoscopy

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Sedation Success rate is defined as: Having 3 consecutive Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale scores of ≤4 after administration of sedative medication
Completing the procedure
Without requiring the use of alternative sedative medication
Without requiring manual or mechanical ventilation

Secondary Outcome Measures:

Treatment Success rate - Treatment Success is defined as a patient (i) completing the procedure (ii) without requiring alternative sedative medications AND (iii) without requiring manual or mechanical ventilation
Proportion of patients willing to be treated again with the same study sedative medication
Proportion of patients who do not recall being awake during the procedure

Estimated Enrollment:	250
Study Start Date:	April 2006
Study Completion Date:	May 2007

Detailed Description:

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, both following pretreatment with an analgesic, fentanyl in patients who are undergoing flexible bronchoscopy.

Following completion of preprocedure assessments, patients will be randomly assigned to 1 of 2 treatment groups at a 2:3 (AQUAVAN initial dose 1 [2.0 mg/kg]:AQUAVAN initial dose 2 [6.5 mg/kg] allocation ratio on the day of the scheduled procedure. Randomization will be stratified by site.

A person skilled in airway management (such as a respiratory therapist, a study nurse, or a clinician) and authorized by the facility in which the colonoscopy is performed 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 analgesic pretreatment (fentanyl citrate injection for pain; lidocaine for topical anesthetic followed by the administration of study medication. 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must be able to understand, either orally or in writing, and be able to consent and complete the 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 predose.
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 or opioid.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306722

Show 25 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

James Jones, MD, PharmD

Eisai Inc.

More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest. 2009 Jan;135(1):41-7. Epub 2008 Jul 18.

Study ID Numbers:	3000-0524, MGI 3000-0524
Study First Received:	March 22, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00306722 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Bronchoscopy
Sedation
AQUAVAN
fospropofol disodium
Flexible bronchoscopy

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Propofol
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010