AzTrials
AzTrials

ColonoscopyPhase 2/3NCT00125424

Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

A Phase 2/3 study testing AQUAVAN® (fospropofol disodium) Injection and Midazolam HCl in people with Colonoscopy and Colonic Polyps, run by Eisai Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonoscopy, Colonic Polyps
What is being tested?
AQUAVAN® (fospropofol disodium) Injection and Midazolam HCl
Type of treatment
Injection or infusion
How many people
125 participants
Where
20 sitesUnited States
Study dates
Jul 2005to Sep 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 has 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
  • Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4

Who cannot join

  • Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine
  • Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines
  • 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 post-procedural instructions
  • Patient for whom the use of fentanyl is contraindicated
  • Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Asheville Gastroenterology Associates/The Endoscopy Center

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Gulf Coast Research Associates, Inc.

    Baton Rouge, Louisiana, 70808

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Welborn Clinic

    Evansville, Indiana, 47713

  • Clinical Research Associates

    Huntsville, Alabama, 35801

  • Gastrointestinal Associates, PA

    Jackson, Mississippi, 39202

  • Memphis Gastroenterology Group, PC

    Memphis, Tennessee, 38120

  • Wisconsin Center for Advance Research

    Milwaukee, Wisconsin, 53215

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • Gastroenterology Clinic

    Monroe, Louisiana, 71201

  • Gastrointestinal Institute

    Nashville, Tennessee, 37203

  • St. Thomas Medical Group, P.C.

    Nashville, Tennessee, 37205

  • Research Associates of New York

    New York, New York, 10021

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Rockford Gastroenterology Associates Ltd.

    Rockford, Illinois, 61107

  • Alamo Research Center

    San Antonio, Texas, 78215

  • Spokane Digestive Diseases Center

    Spokane, Washington, 99207

  • Endoscopic Microsurgery Associates, PA

    Towson, Maryland, 21204

  • Oklahoma Gastroenterology Associates

    Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN® Injection for Procedural Sedation in Patients Undergoing Colonoscopy

Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol, allowing for fast sedation and possibly faster recovery and discharge.

This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.

Read the detailed description

This is a randomized, double-blind study designed to evaluate the dose-response in the sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients undergoing a 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 5 IV treatment groups at an equal allocation ratio (25 patients per arm) on the day of the scheduled procedure. Randomization will be stratified by age and ASA status:

AQUAVAN initial bolus dose 1: 8 mg/kg AQUAVAN initial bolus dose 2: 6.5 mg/kg AQUAVAN initial bolus dose 3: 5 mg/kg AQUAVAN initial bolus dose 4: 2 mg/kg Midazolam initial bolus dose: 0.02 mg/kg

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 a 12-lead electrocardiogram (ECG), pulse oximeter, and blood pressure monitor prior to administration of study medication. All patients will receive an injection of analgesic pretreatment followed by the administration of sedative medication, as described below. This protocol recognizes 2 distinct phases of sedation: Sedation Initiation and Sedation Maintenance. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit, and adverse events as detailed in the protocol. Blood samples will be collected for pharmacokinetic (PK) analysis, also detailed in the protocol.

Being tested
AQUAVAN® (fospropofol disodium) Injection, Midazolam HCl
Keywords
Colonoscopy, Sedation, AQUAVAN, (fospropofol disodium), Endoscopic sedation, Endoscopic outcomes, Endoscopy
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AQUAVAN® (fospropofol disodium) InjectionDrug

  • Midazolam HClDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Three consecutive MOAA/S scores ≤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 (15)

  1. Patient's rating of experience after ready for discharge

  2. Principal Investigator's (PI's) rating at end of procedure

  3. Percentage of patients requiring alternative sedative medication

  4. Number of doses/amount of fentanyl administered

  5. Number of doses of study medication administered

  6. Time to sedation, digital rectal examination, start of procedure, reach splenic flexure, hepatic flexure, cecum, end of procedure, and ready for discharge

  7. Percentage of patients requiring repositioning

  8. Percentage of patients whose procedures are interrupted due to inadequate sedation

  9. Time to ready for discharge from end of procedure

  10. Change from baseline DSST score over time during recovery period

  11. Patient's rating at 24 hour post discharge telephone survey

  12. Duration and percent of time when a patient's MOAA/S score is at each level between the first dose of study medications and fully alert and during the procedure

  13. PI's rating of level of sedation prior to initiation of the procedure

  14. Percentage of patients with a mean MOAA/S of 2 to 4 and 0 to 1 during the procedure

  15. MOAA/S over time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
125 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00125424
Sponsor's protocol ID
3000-0520
Other IDs
GPI 3000-0520
Status last verified
Nov 2008
First submitted
27 Jul 2005
Last updated
7 Nov 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AQUAVAN® (fospropofol disodium) Injection and Midazolam HCl in people with Colonoscopy and Colonic Polyps, run by Eisai Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Three consecutive MOAA/S scores ≤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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00125424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in