Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic PolypectomyPhase 3Kagami_SDSNCT01961349

Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy

A Phase 3 study testing Intralipid, ICI35,868 (Diprivan) and ICI35,868 (Diprivan) + EES0000645/A (SDS) in people with Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy, run by AstraZeneca at 3 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

This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
What is being tested?: Intralipid, ICI35,868 (Diprivan) and ICI35,868 (Diprivan) + EES0000645/A (SDS)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 279 participants
Where: 3 sitesJapan
Study dates: Oct 2013to Mar 2014
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.). Exclusion Criteria:
involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)
ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Research Site
Moriya-shi
Research Site
Shinjuku-ku
Research Site
Yokohama

Other trials in Japan

About this study

Official title: A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy

The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.

Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Being tested: Intralipid, ICI35,868 (Diprivan), ICI35,868 (Diprivan) + EES0000645/A (SDS)
Keywords: sedation, propofol, gastrointestinal endoscopy

What participants receive

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

IntralipidDrug
Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
ICI35,868 (Diprivan)Drug
Treated by Anaesthesiologist
ICI35,868 (Diprivan) + EES0000645/A (SDS)Drug
Treated by Endoscopist with EES0000645/A(SDS)

Study groups in NCT01961349
Study group	Role	What they receive
Group 1	Placebo comparator	Group 1 (placebo group) is treated by Anaesthesiologist Receives: Drug: Intralipid
Group 2	Active comparator	Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist Receives: Drug: ICI35,868 (Diprivan)
Group 3	Active comparator	Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist Receives: Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)

What is being measured

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

Achivement of Target Sedation
The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.
Measured: from scope-in to scope-out

Secondary outcomes (1)

PSSI Total Score
PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)
Measured: at 24-48 h after endoscopy

Timeline

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

Oct 2013Mar 2014

First posted11 Oct 2013 (estimated)
Study startOct 2013
Primary completionMar 2014
Study completionMar 2014

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 Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic PolypectomyStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01961349
Sponsor's protocol ID: D0092C00002
Acronym: Kagami_SDS
Status last verified: Oct 2015
First submitted: 10 Oct 2013
Last updated: 27 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy
ClinicalTrials.gov ID: NCT01961349
Acronym / sponsor ID: Kagami_SDS / D0092C00002
Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Keywords: sedation, propofol, gastrointestinal endoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 279 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson
Study start: Oct 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 11 Oct 2013 (estimated)
Results: Posted 27 Nov 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Placebo comparator	Drug: IntralipidGroup 1 (placebo group) is treated by Anaesthesiologist
Group 2	Active comparator	Drug: ICI35,868 (Diprivan)Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
Group 3	Active comparator	Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist

Who may qualify

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

Key inclusion criteria (6 listed)

1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.). Exclusion Criteria:
involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)

Key exclusion criteria (0 listed)

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
IntralipidTreated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)	Drug	Group 1
ICI35,868 (Diprivan)Treated by Anaesthesiologist	Drug	Group 2
ICI35,868 (Diprivan) + EES0000645/A (SDS)Treated by Endoscopist with EES0000645/A(SDS)	Drug	Group 3

Primary outcome

Achivement of Target Sedation
Time frame: from scope-in to scope-out
The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.

1 secondary outcome

PSSI Total Score
Time frame: at 24-48 h after endoscopy

Results and safety

Results posted to the registry on 27 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	54	51
ICI35,868 Without EES0000645/A	107	101
ICI35,868 With EES0000645/A	111	109

Primary outcome: Achivement of Target Sedation

Time frame: from scope-in to scope-out. Number (95% Confidence Interval). Unit: % of patients

Measure	Placebo n = 51	ICI35,868 Without EES0000645/A n = 101	ICI35,868 With EES0000645/A n = 109
Value	21.6 (11.3 to 35.3)	88.1 (80.2 to 93.7)	94.5 (88.4 to 98.0)

Placebo vs ICI35,868 Without EES0000645/A: p <0.001, Fisher Exact
Placebo vs ICI35,868 With EES0000645/A: p <0.001, Fisher Exact

Population analysed: FAS (Full Analysis Set)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 days. Other adverse events reported at 1.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 51 (0%)	9 of 51 (17.6%)	Not reported
ICI35,868 Without EES0000645/A	0 of 101 (0%)	7 of 101 (6.9%)	Not reported
ICI35,868 With EES0000645/A	0 of 109 (0%)	12 of 109 (11%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D0092C00002\_CSR\_Synopsis.pdfLink provided by the sponsor.

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.

The record lists no contact. Use the official record to reach the sponsor.

3 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?

The sponsor lists 6 inclusion and 0 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 27 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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 27 Nov 2015). 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?

Achivement of Target Sedation (time frame: from scope-in to scope-out). 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 NCT01961349.

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 27 Nov 2015.