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A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation 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: NCT00209573
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 7, 2008
Sponsor:
Collaborators:
PPD
Bio Analytical Research Corporation
MDS Pharma Services
Coghlan Group (Plasma Sample Supplies)
Information provided by:
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date November 7, 2008
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00209573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • Secondary Efficacy Endpoints
  • Time to Fully Recovered from end of procedure
  • Time to Fully Alert from end of procedure
  • Change from baseline DSST score over time during recovery period
  • 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
  • Time to reach splenic flexure, hepatic flexure, cecum, and end of procedure
  • Number of repositionings
  • Number of procedure interruptions due to inadequate sedation
  • Patient's rating of experience after Fully Recovered
  • Patient's rating at 24 hour post discharge telephone survey
  • 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
  • Airway assistance
  • Sedation-related adverse events
  • Laboratory parameters and vital signs
  • Concomitant medications
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Secondary Efficacy Endpoints
  • • Time to Fully Recovered from end of procedure
  • • Time to Fully Alert from end of procedure
  • • Change from baseline DSST score over time during recovery period
  • • 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
  • • Time to reach splenic flexure, hepatic flexure, cecum, and end of procedure
  • • Number of repositionings
  • • Number of procedure interruptions due to inadequate sedation
  • • Patient's rating of experience after Fully Recovered
  • • Patient's rating at 24 hour post discharge telephone survey
  • • 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
  • • Airway assistance
  • • Sedation-related adverse events
  • • Laboratory parameters and vital signs
  • • Concomitant medications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonoscopy
  • Colon Polyps
Intervention  ICMJE Drug: fospropofol disodium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
270
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209573
Other Study ID Numbers  ICMJE 3000-0410
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE
  • PPD
  • Bio Analytical Research Corporation
  • MDS Pharma Services
  • Coghlan Group (Plasma Sample Supplies)
Investigators  ICMJE
Study Director: James Jones, MD,PharmD Eisai Inc.
PRS Account Eisai Inc.
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP