Trial Outcomes & Findings for Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy (NCT NCT01961349)

NCT ID: NCT01961349

Last Updated: 2015-11-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 279 participants
• Primary outcome timeframe: from scope-in to scope-out
• Results posted on: 2015-11-27

Participant Flow

Of the 279 consented subjects, 7 were excluded after screening.

Participant milestones

Measure	Placebo Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
Overall Study STARTED	54	107	111
Overall Study COMPLETED	51	101	109
Overall Study NOT COMPLETED	3	6	2

Reasons for withdrawal

Measure	Placebo Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
Overall Study Withdrawal by Subject	1	4	0
Overall Study Adverse Event	0	0	1
Overall Study registration error, personal reason etc	2	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=51 Participants Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A n=101 Participants ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A n=109 Participants ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse	Total n=261 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 14.3 • n=93 Participants	55.4 years STANDARD_DEVIATION 12.9 • n=4 Participants	57.2 years STANDARD_DEVIATION 14.8 • n=27 Participants	56.8 years STANDARD_DEVIATION 14.0 • n=483 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	36 Participants n=4 Participants	34 Participants n=27 Participants	87 Participants n=483 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	65 Participants n=4 Participants	75 Participants n=27 Participants	174 Participants n=483 Participants

PRIMARY outcome

Timeframe: from scope-in to scope-out

Population: FAS (Full Analysis Set)

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.

Outcome measures

Measure	Placebo n=51 Participants Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A n=101 Participants ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A n=109 Participants ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
Achivement of Target Sedation	21.6 % of patients Interval 11.3 to 35.3	88.1 % of patients Interval 80.2 to 93.7	94.5 % of patients Interval 88.4 to 98.0

SECONDARY outcome

Timeframe: at 24-48 h after endoscopy

Population: FAS (Full Analysis Set)

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)

Outcome measures

Measure	Placebo n=51 Participants Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A n=101 Participants ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A n=109 Participants ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
PSSI Total Score	65.3 Score on a scale (0 - 100) Standard Deviation 19.7	81.2 Score on a scale (0 - 100) Standard Deviation 12.5	80.8 Score on a scale (0 - 100) Standard Deviation 14.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

ICI35,868 Without EES0000645/A

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ICI35,868 With EES0000645/A

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=51 participants at risk Placebo administered by the anaesthesiologist without EES0000645/A	ICI35,868 Without EES0000645/A n=101 participants at risk ICI35,868 administered by the anaesthesiologist without EES0000645/A	ICI35,868 With EES0000645/A n=109 participants at risk ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
Psychiatric disorders disinhibition	0.00% 0/51 • 3 days	2.0% 2/101 • Number of events 2 • 3 days	1.8% 2/109 • Number of events 2 • 3 days
Investigations blood urine present	2.0% 1/51 • Number of events 1 • 3 days	2.0% 2/101 • Number of events 2 • 3 days	2.8% 3/109 • Number of events 3 • 3 days
Nervous system disorders sedation	0.00% 0/51 • 3 days	0.99% 1/101 • Number of events 1 • 3 days	2.8% 3/109 • Number of events 3 • 3 days
Investigations oxygen saturation decreased	2.0% 1/51 • Number of events 1 • 3 days	0.00% 0/101 • 3 days	1.8% 2/109 • Number of events 2 • 3 days
Gastrointestinal disorders Abdominal distension	3.9% 2/51 • Number of events 2 • 3 days	0.99% 1/101 • Number of events 1 • 3 days	0.00% 0/109 • 3 days
Gastrointestinal disorders Abdominal pain lower	9.8% 5/51 • Number of events 5 • 3 days	0.99% 1/101 • Number of events 1 • 3 days	1.8% 2/109 • Number of events 2 • 3 days

Additional Information

Hideo Negi

CO RI&A TA, R&D

Phone: +81 6 4803 3533

Email: H.Negi@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60