SedationPhase 4NCT01127438

A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

A Phase 4 study testing fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose and fospropofol disodium Subgroup 2 Lower Dose in people with Sedation, run by Eisai Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation
What is being tested?: fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose and fospropofol disodium Subgroup 2 Lower Dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 23 sitesUnited States
Study dates: Apr 2010to Jun 2011
Phase: Phase 4
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

Subjects who meet all of the following criteria will be included in the study:

Male and female adult candidates for diagnostic or therapeutic colonoscopy with at least one of the following characteristics:

Subgroup 1: Weight < 60 kg and age >/= 18 to < 65 years and ASA I or II;
Subgroup 2: Weight < 60 kg and age >/= 65 years and/or ASA 3 or 4; or
Subgroup 3: Weight >/=60 kg and age >/= 65 years and/or ASA 3 or 4.

Females of childbearing potential must have a negative beta human chorionic gonadotropin (?hCG) urine pregnancy test at Visit 1 (Screening) and prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device [IUD], or have a vasectomised partner) having starting for at least 1 menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential;
Are willing and able to comply with all aspects of the protocol; and
Provide written informed consent.

Subjects who meet any of the following criteria will be excluded from participation in the study:

Females who are pregnant (positive BhCG urine pregnancy test) or breastfeeding;
Subjects who do not meet nil per os (NPO) requirement of no solid foods within 8 hours and clear fluids up to 3 hours before the procedure (assessed only at Baseline);
Evidence of clinically significant disease or a history of a concomitant medical condition (eg, cardiac, respiratory, gastrointestinal, renal disease) that, in the opinion of the Investigator, could affect the subject's safety or ability to safely complete the study;
Subjects with hypersensitivity to LUSEDRA or any other components of LUSEDRA, including its active metabolite, propofol;
History of drug or alcohol dependency or abuse within approximately the last 2 years; or
The Investigator believes to be medically unfit to receive the study drug or unsuitable for any other reason.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Southern California Permanente Medical Group
Baldwin Park, California, 91706
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Utah Digestive Health Institute
Clinton, Utah, 84015
Ohio State University Medical Center Department of Anesthesiology
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, 22031
Northern Utah Gastroenterology
Logan, Utah, 84341-2534
Center for Advanced Gastroenterology
Maitland, Florida, 32751
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
University of Miami School of Medicine
Miami, Florida, 33136
Research Associates of New York, LLP
New York, New York, 10075
Advance Clinical Research
Odgen, Utah, 84405
Creighton University Medical Center
Omaha, Nebraska, 68131
Hope Research Institute
Phoenix, Arizona, 85050
Digestive Health Associates
Plano, Texas, 75075
Utah Clinical Trials, LLC
Salt Lake City, Utah, 84107
Desta Digestive Disease Medical Center
San Diego, California, 92114
Miami Research Associates
South Miami, Florida, 33143
Clinical Trial Network
Spring, Texas, 77386
Sheridan Clinical Research
Sunrise, Florida, 33323
Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital
Tyrone, Pennsylvania, 16686
Ilumina Clinical Associates
Uniontown, Pennsylvania, 15401
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Read the detailed description

This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.

Conditions: Sedation
Being tested: fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose, fospropofol disodium Subgroup 2 Lower Dose, fospropofol disodium Subgroup 2 Approved Dose, fospropofol disodium Subgroup 3 Lower Dose
Keywords: Monitored anesthesia care sedation

What participants receive

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

fospropofol disodium Subgroup 1 Lower DoseDrug
Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II)
fospropofol disodium Subgroup 1 Approved DoseDrug
(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II)
fospropofol disodium Subgroup 2 Lower DoseDrug
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4
fospropofol disodium Subgroup 2 Approved DoseDrug
(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4
fospropofol disodium Subgroup 3 Lower DoseDrug
(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4
fospropofol disodium Subgroup 3 Approved DoseDrug
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4

Study groups in NCT01127438
Study group	Role	What they receive
fospropofol disodium Subgroup 1 Lower Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 1 Lower Dose
: fospropofol disodium Subgroup 1 Approved Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 1 Approved Dose
fospropofol disodium Subgroup 2 Lower Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 2 Lower Dose
fospropofol disodium Subgroup 2 Approved Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 2 Approved Dose
fospropofol disodium Subgroup 3 Lower Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 3 Lower Dose
fospropofol disodium Subgroup 3 Approved Dose	Active comparator	Not described Receives: Drug: fospropofol disodium Subgroup 3 Approved Dose

What is being measured

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

Number of Participants With Sedation Success
Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.
Measured: Day 1

Secondary outcomes (2)

Number of Participants With Treatment Success
Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.
Measured: Day 1
Number of Participants With Modified Sedation Success
Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.
Measured: Day 1

Timeline

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

Apr 2010Jun 2011

First posted20 May 2010 (estimated)
Study startApr 2010
Primary completionJun 2011
Study completionJun 2011

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01127438
Sponsor's protocol ID: E2083-A001-406
Status last verified: Feb 2013
First submitted: 19 May 2010
Last updated: 8 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
ClinicalTrials.gov ID: NCT01127438
Acronym / sponsor ID: E2083-A001-406
Conditions: Sedation
Keywords: Monitored anesthesia care sedation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 20 May 2010 (estimated)
Results: Posted 8 Feb 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
fospropofol disodium Subgroup 1 Lower Dose	Active comparator	Drug: fospropofol disodium Subgroup 1 Lower Dose
: fospropofol disodium Subgroup 1 Approved Dose	Active comparator	Drug: fospropofol disodium Subgroup 1 Approved Dose
fospropofol disodium Subgroup 2 Lower Dose	Active comparator	Drug: fospropofol disodium Subgroup 2 Lower Dose
fospropofol disodium Subgroup 2 Approved Dose	Active comparator	Drug: fospropofol disodium Subgroup 2 Approved Dose
fospropofol disodium Subgroup 3 Lower Dose	Active comparator	Drug: fospropofol disodium Subgroup 3 Lower Dose
fospropofol disodium Subgroup 3 Approved Dose	Active comparator	Drug: fospropofol disodium Subgroup 3 Approved Dose

Who may qualify

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

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 Subgroup 1 Lower DoseDose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II)	Drug	fospropofol disodium Subgroup 1 Lower Dose
fospropofol disodium Subgroup 1 Approved Dose(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II)	Drug	: fospropofol disodium Subgroup 1 Approved Dose
fospropofol disodium Subgroup 2 Lower DoseDose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4	Drug	fospropofol disodium Subgroup 2 Lower Dose
fospropofol disodium Subgroup 2 Approved Dose(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4	Drug	fospropofol disodium Subgroup 2 Approved Dose
fospropofol disodium Subgroup 3 Lower Dose(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4	Drug	fospropofol disodium Subgroup 3 Lower Dose
fospropofol disodium Subgroup 3 Approved DoseDose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4	Drug	fospropofol disodium Subgroup 3 Approved Dose

Primary outcome

Number of Participants With Sedation Success
Time frame: Day 1
Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.

2 secondary outcomes

Number of Participants With Treatment Success
Time frame: Day 1
Number of Participants With Modified Sedation Success
Time frame: Day 1

Results and safety

Results posted to the registry on 8 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subgroup 1, Lower Dose	25	25
Subgroup 1, Approved Dose	25	25
Subgroup 2, Lower Dose	26	26
Subgroup 2, Approved Dose	24	24
Subgroup 3, Lower Dose	28	28
Subgroup 3, Approved Dose	25	25

Primary outcome: Number of Participants With Sedation Success

Time frame: Day 1. Number. Unit: Participants

Measure	Subgroup 1, Lower Dose n = 25	Subgroup 1, Approved Dose n = 25	Subgroup 2, Lower Dose n = 25	Subgroup 2, Approved Dose n = 25	Subgroup 3, Lower Dose n = 28	Subgroup 3, Approved Dose n = 25
Value	18	24	18	21	19	24

Population analysed: Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lower Dose	1 of 79 (1.3%)	23 of 79 (29.1%)	Not reported
Approved Dose	2 of 74 (2.7%)	15 of 74 (20.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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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.

Jim Ferry study director

Eisai Inc.

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Feb 2013). 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?

Number of Participants With Sedation Success (time frame: Day 1). 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 NCT01127438.

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 8 Feb 2013.