Study to Assess Safety and Efficacy of AQUAVAN® Injection for Sedation During Cardiac Catheterization

November 6, 2008 updated by: Eisai Inc.

A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Percutaneous Coronary (PC) Procedures

The anticipation of pain and discomfort, a diagnosis, and other intrinsic unknowns make patients anxious both prior to and during a procedure. Therefore, the main goal of sedation with analgesia used during various diagnostic, therapeutic, or surgical procedures is to relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of sedation for any given patient is one that allows the patient to tolerate the procedure and provides an appropriate safety margin. This was a study designed to examine the safety and efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl following pretreatment with fentanyl citrate injection (for pain relief) in producing sedation in patients undergoing single cardiac catheterization procedures.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This was a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN® Injection (hereafter referred to as AQUAVAN) versus the reference drug, midazolam HCl (hereafter referred to as midazolam) following pretreatment with fentanyl citrate injection (hereafter referred to as fentanyl) in producing sedation in male and female patients undergoing single PC procedures.

Screening assessments were done within 2 weeks of scheduled procedures. After completion of preprocedural sedation assessments, patients were randomly assigned to 1 of the 2 treatment groups at a 3:1 (AQUAVAN: midazolam) allocation ratio on the day of the scheduled procedure (Day 0) via an Interactive Voice Response System (IVRS). Randomization was stratified by site.

All patients, regardless of treatment group assignment, received fentanyl as an analgesic pretreatment. Supplemental doses of fentanyl could be administered if the patient reported pain or if analgesia was inadequate, as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation. At no time was fentanyl to be administered to increase sedation levels.

AQUAVAN or midazolam was administered by intravenous (i.v.) bolus to induce a state of minimal-to-moderate (procedural) s sedation, defined as a score of ≤4 on the Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale. Supplemental doses were administered, if necessary, to increase the depth or duration of sedation. Supplemental doses were not administered if the Modified OAA/S score was ≤2 or if there was no purposeful response to stimulation. Patient and Investigator assessments were used to confirm that the depth of sedation met the goals of sedation, reduced anxiety, and awareness.

Follow-up patient assessments were conducted in a telephone interview 24 hours following treatment and during a clinic visit 2 to 5 days following treatment.

Study Type

Interventional

Enrollment

110

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient provided signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
  2. Patient was at least 18 years of age at the time of screening (Prior to Amendment 2 [dated 04 February 2005], the patient was required to be between 18 and 65 years of age, inclusive. Three subjects were randomized under this earlier inclusion criteria).
  3. If female, patient was surgically sterile, postmenopausal or not pregnant or lactating and had 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 Predosing Periods.
  4. Patient met American Society of Anesthesiologists (ASA)13, 14 Physical Status Classification System level I to III; and
  5. Patient was an inpatient or outpatient scheduled to undergo a single PC procedure.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstrate that AQUAVAN was effective in providing adequate sedation in patients undergoing percutaneous coronary (PC) procedures.

Secondary Outcome Measures

Outcome Measure
Treatment-emergent adverse events, Sedation-related adverse events, and airway Assistance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

PPD

Investigators

  • Study Director: James Jones, MD,PharmD, Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2008

Last Update Submitted That Met QC Criteria

November 6, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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