Procedural SedationPhase 2/3NCT00327392
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
A Phase 2/3 study testing AQUAVAN® (fospropofol disodium) Injection in people with Procedural Sedation, run by Eisai Inc. at 15 sites in United States.
Trial summary
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- AQUAVAN® (fospropofol disodium) Injection
- Type of treatment
- Injection or infusion
- How many people
- 123 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2006to Dec 2007
- Phase
- Phase 2/3
- 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 must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
- Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures at the time of screening.
- If female, patient must be 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 predose.
- Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
Who cannot join
- Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
- Patient has a Mallampati Classification Score of 4; or a Mallampati Classification Score of 3 and a thyromental distance <4 cm, or for any other reason has a difficult airway, in the opinion of the Principal Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
- Patient has participated in an investigational drug study within 1 month prior to study start.
- Patient is unwilling to adhere to pre- and postprocedural instructions.
- Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
St. Louis Women's Healthcare Group
Chesterfield, Missouri, 63017
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, 29204
Dallas VA Medical Center
Dallas, Texas, 75216
Duke University Medical Center
Durham, North Carolina, 27710
Borland-Groover Clinic
Jacksonville, Florida, 32256
University of Louisville
Louisville, Kentucky, 40202
International Heart Institute of Montana
Missoula, Montana, 59802
Carolina Urologic Research
Myrtle Beach, South Carolina, 29572
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
Precision Trials
Phoenix, Arizona, 85032
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Physicians' Research Options
Sandy City, Utah, 84070
Medical Research Institute, Inc.
Slidell, Louisiana, 70458
Medical Research Institute
Slidell, Louisiana, 70458
About this study
Official title: A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
Read the detailed description
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.
- Conditions
- Procedural Sedation
- Being tested
- AQUAVAN® (fospropofol disodium) Injection
- Keywords
- Arthroscopy, AV Shunt, Bunion, Dilatation and Curettage, Esophagogastroduodenoscopy, Hysteroscopy, Lithotripsy, Rotator Cuff/ Shoulder, Transesophageal Echocardiography, Ureteroscopy, AQUAVAN, Sedation
- Medical subject headings
- Arteriovenous Fistula, Bunion, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUAVAN® (fospropofol disodium) InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMay 2006
- Study completionDec 2007
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 Procedural SedationStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James B Jones, MD, PharmD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327392
- Sponsor's protocol ID
- 3000-0523
- Status last verified
- May 2012
- First submitted
- 16 May 2006
- Last updated
- 20 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures
- ClinicalTrials.gov ID
- NCT00327392
- Acronym / sponsor ID
- 3000-0523
- Conditions
- Procedural Sedation
- Keywords
- Arthroscopy, AV Shunt, Bunion, Dilatation and Curettage, Esophagogastroduodenoscopy, Hysteroscopy, Lithotripsy, Rotator Cuff/ Shoulder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 18 May 2006 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
Detailed description
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
- Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures at the time of screening.
- If female, patient must be 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 predose.
- Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
Key exclusion criteria (7 listed)
- Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
- Patient has a Mallampati Classification Score of 4; or a Mallampati Classification Score of 3 and a thyromental distance <4 cm, or for any other reason has a difficult airway, in the opinion of the Principal Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
- Patient has participated in an investigational drug study within 1 month prior to study start.
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 |
|---|---|---|
| AQUAVAN® (fospropofol disodium) Injection | Drug | – |
Primary outcome
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 B Jones, MD, PharmD study director
Eisai Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AQUAVAN® (fospropofol disodium) Injection in people with Procedural Sedation, run by Eisai Inc. at 15 sites in United States.
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 7 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: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 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?
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2012.