- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00209573
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
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 Colonoscopy Procedures
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN® Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate injection, in producing sedation in patients undergoing colonoscopy.
Randomization will be stratified by site.
Following completion of pre-procedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v.
treatment groups at a 3:1 (AQUAVAN® Injection: midazolam HCl) allocation ratio.
All study patients, irrespective of treatment group assignment, will receive fentanyl citrate injection as an analgesic pretreatment.
Supplemental doses of fentanyl citrate injection may be administered if the patient reports pain or if inadequate analgesia is present as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation.
At no time should fentanyl citrate injection be administered to increase sedation levels.
AQUAVAN® Injection and midazolam HCl will be administered to induce a state of adequate sedation, defined as a Modified Observer's Assessment of Alertness / Sedation (OAA/S) score of 4 or less.
Supplemental doses will be administered to increase depth or duration of sedation.
Supplemental doses will not be administered if the Modified OAA/S score is 2 or less or if there is no purposeful response to stimulation.
The depth of sedation will be measured by the Modified OAA/S scale, a validated measure.
Patient and Investigator assessments will be used to confirm the depth of sedation provided met the goals of sedation, reduction of anxiet, and reduced awareness.
Study Type
Interventional
Enrollment
270
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Change from baseline DSST score over time during recovery period
|
Patient's rating at 24 hour post discharge telephone survey
|
Secondary Efficacy Endpoints
|
Time to Fully Recovered from end of procedure
|
Time to Fully Alert from end of procedure
|
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
|
Duration of sedation
|
Number of doses of study medication administered for the procedure
|
Time to sedation
|
Number of procedure interruptions due to inadequate sedation
|
Patient's rating of experience after Fully Recovered
|
Investigator's rating at end of procedure
|
Blinded evaluator's rating after patient is Fully Recovered
|
Safety Endpoints
|
Nature, frequency, severity, relationship to treatment, and outcome of all adverse events
|
Laboratory parameters and vital signs
|
Airway assistance
|
Concomitant medications
|
Time to reach splenic flexure, hepatic flexure, cecum, and end of procedure
|
Number of repositionings
|
Sedation-related adverse events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
September 1, 2004
Study Completion (Actual)
December 1, 2004
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3000-0410
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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