ArthroscopyPhase 3NCT00209560

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

A Phase 3 study testing fospropofol disodium in people with Arthroscopy and Bunionectomy, run by Eisai Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroscopy, Bunionectomy, Osteotomy
What is being tested?: fospropofol disodium
How many people: 168 participants
Where: No sites listed yet
Study dates: Oct 2004to Mar 2005
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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.

Who cannot join

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.

Show all 9Show fewer

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).

About this study

Official title: A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Minor Surgical Procedures

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.

Read the detailed description

Randomized, open label, multi-center,midazolam 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 minor surgical and/or therapeutic procedures. 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 majority of patients who are pre-medicated with fentanyl citrate injection.

Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice.

[new paragraph] All patients were pre-medicated with fentanyl citrate as an analgesic.

The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation. In outpatient minor surgical procedures, sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management. Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia. This injection is used following pretreatment with fentanyl citrate for pain management.

Conditions: Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
Being tested: fospropofol disodium
Keywords: AQUAVAN® Injection, Midazolam, Minor surgical procedures, Sedation
Medical subject headings: Median Neuropathy

What participants receive

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

fospropofol disodiumDrug

What is being measured

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

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
Measured: 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
Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.
Measured: At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status

Timeline

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

Oct 2004Mar 2005

First posted21 Sep 2005 (estimated)
Study startOct 2004
Study completionMar 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArthroscopyStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00209560
Sponsor's protocol ID: 3000-0412
Status last verified: Jul 2014
First submitted: 13 Sep 2005
Last updated: 9 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arthroscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Minor Surgical Procedures
ClinicalTrials.gov ID: NCT00209560
Acronym / sponsor ID: 3000-0412
Conditions: Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
Keywords: AQUAVAN® Injection, Midazolam, Minor surgical procedures, Sedation
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 168 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Collaborators: PPD Development, LP, Covance
Study start: Oct 2004
Study completion: Mar 2005
First posted: 21 Sep 2005 (estimated)
Results: Posted 19 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice.

[new paragraph] All patients were pre-medicated with fentanyl citrate as an analgesic.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fospropofol disodium	Drug	–

Primary outcome

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

1 secondary outcome

Time to Fully Alert From the End of the Procedure
Time frame: At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status

Results and safety

Results posted to the registry on 19 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fospropofol Disodium	121	120
Midazolam	42	42

Primary outcome: 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

Time frame: Sedation success was assessed at 2 minute intervals until the end of the procedure. Number (95% Confidence Interval). Unit: participants

Measure	Fospropofol Disodium n = 121	Midazolam n = 42
pPI Population Sedation Success	94.2 (94.2)	78.6 (63.2 to 89.7)
mITT Population Sedation Success	94.2 (88.4 to 97.6)	78.6 (63.2 to 89.7)

Population analysed: The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator's decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fospropofol Disodium	1 of 121 (0.8%)	104 of 121 (86%)	Not reported
Midazolam	0 of 42 (0%)	31 of 42 (73.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroscopy

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
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Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Jones, MD, PharmD study director

Eisai Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fospropofol disodium in people with Arthroscopy and Bunionectomy, run by Eisai Inc..

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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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 (time frame: Sedation success was assessed at 2 minute intervals until the end of the procedure). 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 NCT00209560.

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 9 Jan 2015.