An Effectiveness & Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy - Article Caverject; Edex Kit
Clinical Trial: An Effectiveness & Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
This study is not yet open for patient recruitment.
Verified by MGI Pharma November 2005
| Drug: AQUAVAN® (fospropofol disodium) Injection |
Drug: Midazolam HCI
|Phase III |
MedlinePlus related topics: Colonic Polyps
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 Colonoscopy
Expected Total Enrollment: 300
Study start: December 2005; Expected completion: April 2006
Last follow-up: March 2006; Data entry closure: April 2006
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 minimally effective 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 preprocedure assessments, patients will be randomly assigned to 1 of 3 treatment groups at a 2:3:1 (AQUAVAN initial dose 1 [minimally effective 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.
Number of patients/site: Approximately 300 patients at up to 50 sites will be randomized into this study.
Study Country Location: United States
- 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.
- 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 12-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.
Location and Contact Information
Endoscopic Microsurgery Associates, PA, Towson, Maryland, 21204, United States
Research Associates of New York (New York Gastroenterology Associates), New York, New York, 10021, United States
James Jones, MD, PharmD, Study Director, MGI Pharma
Last Updated: December 8, 2005
Record first received: December 1, 2005
ClinicalTrials.gov Identifier: NCT00261599
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10