Clinical trial NCT00261599: An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Conscious Sedation
Keywords: Colonoscopy
Sedation
AQUAVAN
Fospropofol disodium
Colon polyps
Endoscopic outcomes
Endoscopic sedation
Endoscopy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Fresno
country: United States
facility: UCSF-Fresno/University Medical Center
state: California
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Medical Center/Clarian Health Partner
state: Indiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Laurel
country: United States
facility: Maryland Digestive Diseases Center
state: Maryland
city: Prince Frederick
country: United States
facility: Shah Associates
state: Maryland
city: Royal Oak
country: United States
facility: Oakland Colon & Rectal Associates
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: New York
country: United States
facility: Research Associates of New York (New York Gastroenterology Associates)
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Portland
country: United States
facility: WestHills Gastroenterology Associates
state: Oregon
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Nashville
country: United States
facility: Gastrointestinal Institute
state: Tennessee
city: San Antonio
country: United States
facility: Alamo Research Center
state: Texas
city: Spokane
country: United States
facility: Spokane Digestive Disease Center
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advance Research
state: Wisconsin
Study officials:
affiliation: Eisai Inc.
name: James Jones, MD, PharmD
role: STUDY_DIRECTOR
References: