Gastrointestinal EndoscopyPhase 2NCT01189604

Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

A Phase 2 study testing ICI35,868 (propofol) in people with Gastrointestinal Endoscopy and Gastrointestinal Polypectomy, run by AstraZeneca at 2 sites in Japan.

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

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Gastrointestinal Endoscopy, Gastrointestinal Polypectomy
What is being tested?: ICI35,868 (propofol)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 123 participants
Where: 2 sitesJapan
Study dates: Aug 2010to Nov 2010
Phase: Phase 2
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Who cannot join

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Research Site
Isesaki, Gunma
Research Site
Moriya, Ibaragi

Other trials in Japan

About this study

Official title: A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Conditions: Gastrointestinal Endoscopy, Gastrointestinal Polypectomy
Being tested: Placebo, ICI35,868 (propofol)
Keywords: propofol endoscopy sedation

What participants receive

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

PlaceboDrug
Infusion of placebo, same infusion rates as for arm 2
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
ICI35,868 (propofol)Drug
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Study groups in NCT01189604
Study group	Role	What they receive
Arm1 - Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Arm 2 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)
Arm 3 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)
Arm 4 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)
Arm 5 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)
Arm 6 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)
Arm 7 - ICI35,868 (propofol)	Active comparator	Not described Receives: Drug: ICI35,868 (propofol)

What is being measured

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

Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Measured: 2 minutes from the beginning of the maintenance period
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Measured: 4 minutes from the beginning of the maintenance period

Secondary outcomes (3)

Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).
Measured: 24 - 48 hours after completion of the procedure
Blood Concentrations of Propofol
Blood concentration of ICI35,868 (propofol)
Measured: At the end of the initiation period and every 2 minutes during the maintenance period
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Measured: Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)

Timeline

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

Aug 2010Nov 2010

First posted26 Aug 2010 (estimated)
Study startAug 2010
Primary completionNov 2010
Study completionNov 2010

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 Gastrointestinal EndoscopyStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01189604
Sponsor's protocol ID: D0092C00001
Status last verified: Dec 2011
First submitted: 25 Aug 2010
Last updated: 19 Dec 2011
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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)
ClinicalTrials.gov ID: NCT01189604
Acronym / sponsor ID: D0092C00001
Conditions: Gastrointestinal Endoscopy, Gastrointestinal Polypectomy
Keywords: propofol endoscopy sedation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson K.K. Medical Company
Study start: Aug 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 26 Aug 2010 (estimated)
Results: Posted 13 Dec 2011

Clinical summary

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

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 7

Arm	Type	Receives
Arm1 - Placebo	Placebo comparator	Drug: Placebo
Arm 2 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)
Arm 3 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)
Arm 4 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)
Arm 5 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)
Arm 6 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)
Arm 7 - ICI35,868 (propofol)	Active comparator	Drug: ICI35,868 (propofol)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Key exclusion criteria (3 listed)

American Society of Anesthesiologists (ASA) grade III, IV V and VI
Baseline oxygen saturation<90% (room air)
Body Mass Index (BMI) >=35

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
PlaceboInfusion of placebo, same infusion rates as for arm 2	Drug	Arm1 - Placebo
ICI35,868 (propofol)Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute	Drug	Arm 2 - ICI35,868 (propofol)
ICI35,868 (propofol)Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute	Drug	Arm 3 - ICI35,868 (propofol)
ICI35,868 (propofol)Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute	Drug	Arm 4 - ICI35,868 (propofol)
ICI35,868 (propofol)Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute	Drug	Arm 5 - ICI35,868 (propofol)
ICI35,868 (propofol)Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute	Drug	Arm 6 - ICI35,868 (propofol)
ICI35,868 (propofol)Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute	Drug	Arm 7 - ICI35,868 (propofol)

Primary outcome

Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
Time frame: 2 minutes from the beginning of the maintenance period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
Time frame: 4 minutes from the beginning of the maintenance period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.

3 secondary outcomes

Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
Time frame: 24 - 48 hours after completion of the procedure
Blood Concentrations of Propofol
Time frame: At the end of the initiation period and every 2 minutes during the maintenance period
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
Time frame: Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)

Results and safety

Results posted to the registry on 13 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 - Placebo	21	20
Arm 2 - ICI35,868 (Propofol)	21	20
Arm 3 - ICI35,868 (Propofol)	20	20
Arm 4 - ICI35,868 (Propofol)	20	20
Arm 5 - ICI35,868 (Propofol)	20	18
Arm 6 - ICI35,868 (Propofol)	11	10
Arm 7 - ICI35,868 (Propofol)	10	9

Primary outcome: Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period

Time frame: 2 minutes from the beginning of the maintenance period. Number. Unit: Participants

Measure	Arm 1 - Placebo n = 20	Arm 2 - ICI35,868 (Propofol) n = 20	Arm 3 - ICI35,868 (Propofol) n = 20	Arm 4 - ICI35,868 (Propofol) n = 20	Arm 5 - ICI35,868 (Propofol) n = 20	Arm 6 - ICI35,868 (Propofol) n = 10	Arm 7 - ICI35,868 (Propofol) n = 10
MOAA/S Score 0-1	0	0	0	1	1	1	0
MOAA/S Score 2-4	0	2	6	6	14	5	3
MOAA/S Score 5	20	18	14	13	5	4	7

Primary outcome: Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period

Time frame: 4 minutes from the beginning of the maintenance period. Number. Unit: Participants

Measure	Arm 1 - Placebo n = 20	Arm 2 - ICI35,868 (Propofol) n = 20	Arm 3 - ICI35,868 (Propofol) n = 20	Arm 4 - ICI35,868 (Propofol) n = 20	Arm 5 - ICI35,868 (Propofol) n = 20	Arm 6 - ICI35,868 (Propofol) n = 10	Arm 7 - ICI35,868 (Propofol) n = 10
MOAA/S Score 0-1	0	0	0	1	3	1	0
MOAA/S Score 2-4	0	1	7	6	16	5	4
MOAA/S Score 5	20	19	13	13	1	4	6

3 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
Arm 1 - Placebo	0 of 20 (0%)	5 of 20 (25%)	Not reported
Arm 2 - ICI35,868 (Propofol)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Arm 3 - ICI35,868 (Propofol)	0 of 20 (0%)	0 of 20 (0%)	Not reported
Arm 4 - ICI35,868 (Propofol)	0 of 20 (0%)	1 of 20 (5%)	Not reported
Arm 5 - ICI35,868 (Propofol)	0 of 20 (0%)	6 of 20 (30%)	Not reported
Arm 6 - ICI35,868 (Propofol)	0 of 10 (0%)	1 of 10 (10%)	Not reported
Arm 7 - ICI35,868 (Propofol)	0 of 10 (0%)	2 of 10 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
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.

Masataka Date, M.D., Ph.D. study director

Physician Group, Clinical Division, R&D, Astrazeneca K.K.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICI35,868 (propofol) in people with Gastrointestinal Endoscopy and Gastrointestinal Polypectomy, run by AstraZeneca at 2 sites in Japan.

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 2 inclusion and 3 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Dec 2011). 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?

Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period (time frame: 2 minutes from the beginning of the maintenance period). The study lists 2 primary outcomes in all. 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 NCT01189604.

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 19 Dec 2011.