A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy

NCT00209573 | Completed Phase 3

• 1 other identifier: 3000-0410
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.

Conditions

Colonoscopy; Colon Polyps

Keywords

Colonoscopy; Sedation

Outcome Measures

Primary Outcomes (1)

• The primary efficacy hypothesis was that AQUAVAN could sedate (≥3 consecutive Modified OAA/S scores ≤4) patients AND that they could complete the procedure successfully without requiring alternative sedative medication AND without requiring manual or

Secondary Outcomes (21)

• Secondary Efficacy Endpoints

• Time to Fully Recovered from end of procedure

• Time to Fully Alert from end of procedure

• Change from baseline DSST score over time during recovery period

• Duration and percent of time when a patient's Modified OAA/S score is at each level between the first dose of study medications and Fully Alert, inclusive

Interventions

fospropofol disodium DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study;
• Patient, if female, were surgically sterile, postmenopausal or non-pregnant and non lactating 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 periods; and
• Patient met American Society of Anesthesiologists (ASA) Physical Status Classification System of I to III.

You may not qualify if:

• Patient had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine;
• Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
• Patient had condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management;
• Patient participated in an investigational drug study within 1 month prior to study start;
• Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations;
• Patient was unwilling to adhere to pre- and postprocedural instructions; or
• Patient for whom the use of fentanyl or midazolam was contraindicated.

Sponsors & Collaborators

• Eisai Inc.: lead
• PPD Development, LP: collaborator
• Bio Analytical Research Corporation: collaborator
• MDS Pharma Services: collaborator
• Coghlan Group (Plasma Sample Supplies): collaborator

MeSH Terms

Conditions

Colonic Polyps

Interventions

fospropofol

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• James Jones, MD,PharmD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 7, 2008

Record last verified: 2008-11