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

This study has been completed.
Sponsor:
Collaborators:
Omnicare Clinical Research
Bio Analytical Research Corporation
MDS Pharma Services
The Coghlan Group (Plasma Sample Supplies)
HHI Clinical Research (Biostatistics)
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00209534
First received: September 13, 2005
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Colonoscopy
Colon Polyps
Drug: fospropofol disodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 200
Study Start Date: January 2003
Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
Investigators
Study Director: James Jones, MD,PharmD Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209534     History of Changes
Other Study ID Numbers: 3000-0207
Study First Received: September 13, 2005
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Fospropofol disodium
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 20, 2014