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A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00209534
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 4, 2009
Information provided by:

Study Description
Brief Summary:
This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Colon Polyps Drug: fospropofol disodium Phase 2

Detailed Description:
Randomized, open label, multi-center, adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing elective colonoscopy. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in a majority of patients who are pre-medicated with fentanyl citrate injection.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
Study Start Date : January 2003
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients.

Secondary Outcome Measures :
  1. Efficacy variables included: time to sedation, time to Fully Alert, time to Fully Recovered, time to Ready for Discharge, Modified OAA/S scores over time, number of doses and amount of AQUAVAN, and Patient and Physician Satisfaction Surveys.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients provided written informed consent after receiving a full explanation of the extent and nature of the study.
  2. Patients were >=18 years of age to ≤60 years (a subset of up to 50 patients >60 years and <85 years of age was allowed).
  3. Patients, if female, were surgically sterile, postmenopausal or non-pregnant 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.
  4. Body mass index (BMI) between 20 and 28.
  5. Body weight between 50 kg and 100 kg.
  6. Patients had an ASA Physical Classification System status of I or II;
  7. Patients required an elective colonoscopy procedure that was anticipated to be performed in <60 minutes (i.e., procedure was predicted to be uncomplicated); desired sedation for the colonoscopy procedure; and were determined by the Investigator to be physically capable of maintaining an adequate airway during mild-to-moderate sedation.

Exclusion Criteria:

  1. Patients ingested benzodiazepines or barbiturates within 14 days of study start, with the exception of phenobarbital, which required a 21-day washout.
  2. Patients ingested opioids within 72 hours of study start.
  3. Patients had current symptoms of upper respiratory infection.
  4. Patients had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
  5. Patients had current signs of significant hiatal hernia, esophageal reflux, or heartburn which, in the opinion of the Investigator, could interfere with maintenance of an adequate airway.
  6. Patients had a history of alcohol or drug abuse within the past 12 months;
  7. Patients ingested alcohol or caffeine within 12 hours prior to admission into the study.
  8. Patients participated in an investigational drug study within 1 month prior to study start.
  9. Patients were unwilling to adhere to preprocedural and postprocedural instructions.
  10. Patients donated >300 mL of blood within 1 month prior to study start; or
  11. Patients were exposed to AQUAVAN in a previous clinical trial.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209534

Sponsors and Collaborators
Eisai Inc.
Omnicare Clinical Research
Bio Analytical Research Corporation
MDS Pharma Services
The Coghlan Group (Plasma Sample Supplies)
HHI Clinical Research (Biostatistics)
Study Director: James Jones, MD,PharmD Eisai Inc.
More Information

ClinicalTrials.gov Identifier: NCT00209534     History of Changes
Other Study ID Numbers: 3000-0207
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs