ColonoscopyPhase 2NCT00209534

A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy

A Phase 2 study testing fospropofol disodium in people with Colonoscopy and Colon Polyps, run by Eisai Inc..

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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colonoscopy, Colon Polyps
What is being tested?: fospropofol disodium
How many people: 200 participants
Where: No sites listed yet
Study dates: Jan 2003to Feb 2004
Phase: Phase 2
Are there results?: None posted in the registry

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients provided written informed consent after receiving a full explanation of the extent and nature of the study.
Patients were >=18 years of age to ≤60 years (a subset of up to 50 patients >60 years and <85 years of age was allowed).
Patients, if female, were surgically sterile, postmenopausal or non-pregnant 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.
Body mass index (BMI) between 20 and 28.
Body weight between 50 kg and 100 kg.
Patients had an ASA Physical Classification System status of I or II;
Patients required an elective colonoscopy procedure that was anticipated to be performed in <60 minutes (i.e., procedure was predicted to be uncomplicated); desired sedation for the colonoscopy procedure; and were determined by the Investigator to be physically capable of maintaining an adequate airway during mild-to-moderate sedation.

Who cannot join

Patients ingested benzodiazepines or barbiturates within 14 days of study start, with the exception of phenobarbital, which required a 21-day washout.
Patients ingested opioids within 72 hours of study start.
Patients had current symptoms of upper respiratory infection.
Patients had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
Patients had current signs of significant hiatal hernia, esophageal reflux, or heartburn which, in the opinion of the Investigator, could interfere with maintenance of an adequate airway.
Patients had a history of alcohol or drug abuse within the past 12 months;

Show all 11Show fewer

Patients ingested alcohol or caffeine within 12 hours prior to admission into the study.
Patients participated in an investigational drug study within 1 month prior to study start.
Patients were unwilling to adhere to preprocedural and postprocedural instructions.
Patients donated >300 mL of blood within 1 month prior to study start; or
Patients were exposed to AQUAVAN in a previous clinical trial.

About this study

Official title: A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy

This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. 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.

Read the detailed description

Randomized, open label, multi-center, 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 elective colonoscopy. 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 a majority of patients who are pre-medicated with fentanyl citrate injection.

Conditions: Colonoscopy, Colon Polyps
Being tested: fospropofol disodium
Medical subject headings: Colonic Polyps

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.

The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients.

Secondary outcomes (1)

Efficacy variables included: time to sedation, time to Fully Alert, time to Fully Recovered, time to Ready for Discharge, Modified OAA/S scores over time, number of doses and amount of AQUAVAN, and Patient and Physician Satisfaction Surveys.

Timeline

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

Jan 2003Feb 2004

First posted21 Sep 2005 (estimated)
Study startJan 2003
Study completionFeb 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ColonoscopyStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00209534
Sponsor's protocol ID: 3000-0207
Status last verified: Dec 2009
First submitted: 13 Sep 2005
Last updated: 4 Dec 2009
Results posted: 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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
ClinicalTrials.gov ID: NCT00209534
Acronym / sponsor ID: 3000-0207
Conditions: Colonoscopy, Colon Polyps
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Collaborators: Omnicare Clinical Research, Bio Analytical Research Corporation, MDS Pharma Services, The Coghlan Group (Plasma Sample Supplies), HHI Clinical Research (Biostatistics)
Study start: Jan 2003
Study completion: Feb 2004 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Not posted in the source record

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: Factorial
Masking: None (open label)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients provided written informed consent after receiving a full explanation of the extent and nature of the study.
Patients were >=18 years of age to ≤60 years (a subset of up to 50 patients >60 years and <85 years of age was allowed).
Patients, if female, were surgically sterile, postmenopausal or non-pregnant 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.
Body mass index (BMI) between 20 and 28.
Body weight between 50 kg and 100 kg.

Key exclusion criteria (11 listed)

Patients ingested benzodiazepines or barbiturates within 14 days of study start, with the exception of phenobarbital, which required a 21-day washout.
Patients ingested opioids within 72 hours of study start.
Patients had current symptoms of upper respiratory infection.
Patients had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
Patients had current signs of significant hiatal hernia, esophageal reflux, or heartburn which, in the opinion of the Investigator, could interfere with maintenance of an adequate airway.

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

The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients.

1 secondary outcome

Efficacy variables included: time to sedation, time to Fully Alert, time to Fully Recovered, time to Ready for Discharge, Modified OAA/S scores over time, number of doses and amount of AQUAVAN, and Patient and Physician Satisfaction Surveys.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.

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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 Jones, MD,PharmD study director

Eisai Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fospropofol disodium in people with Colonoscopy and Colon Polyps, 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 7 inclusion and 11 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 4 Dec 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients.. 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 NCT00209534.

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 4 Dec 2009.