A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures

NCT00209560 | Terminated Phase 3 Results

• 1 other identifier: 3000-0412
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.

Conditions

Arthroscopy; Bunionectomy; Osteotomy; Carpal Tunnel

Keywords

AQUAVAN® Injection; Midazolam; Minor surgical procedures; Sedation

Outcome Measures

Primary Outcomes (1)

• Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation

  The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined. Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze

  Sedation success was assessed at 2 minute intervals until the end of the procedure

Secondary Outcomes (1)

• Time to Fully Alert From the End of the Procedure

  At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status

Interventions

fospropofol disodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient provided signed/dated Informed Consent and HIPAA Authorization after receiving a full explanation of the extent and nature of the study.
• Patient was at least 18 years of age at the time of screening. (Prior to Amendment 1, dated 03 February 2005, this criterion restricted enrollment to patients who were ≥18 and ≤65 years of age. To ensure that safe dosing levels were administered to patients \>65 years of age, AQUAVAN and midazolam dosing levels were reduced when compared with patients between 18 and 65 years of age, inclusive. The majority of patients were enrolled prior to 03 February 2005.)
• Female patient must have been surgically sterile, postmenopausal, or not pregnant or lactating, and must have 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 predosing periods.
• Patient met the American Society of Anesthesiologists (ASA) Physical Status Classification System of I to III.
• Patient may have been an inpatient or outpatient scheduled to undergo a single minor surgical and/or therapeutic procedure.

You may not qualify if:

• 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 had 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.
• The use of fentanyl or midazolam was contraindicated for the patient.
• Patient had experienced multiple concurrent injuries or trauma.
• Patient was scheduled to undergo multiple same-day procedures (eg, bunionectomies on both feet).

Sponsors & Collaborators

• Eisai Inc.: lead
• PPD Development, LP: collaborator
• Covance: collaborator

MeSH Terms

Conditions

Median Neuropathy

Interventions

fospropofol

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Analysis of results from a previous fospropofol study (3000-0410) completed during the enrollment of this study indicated that the dosing regimen needed to be re-evaluated. The study was prematurely terminated after 168 subjects were randomized.

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Inc

1-888-422-4743

Study Officials

• James Jones, MD, PharmD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2004
• Study Completion: March 1, 2005
• Last Updated: January 9, 2015
• Results First Posted: June 19, 2012

Record last verified: 2014-07