Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Conditions
Keywords
sedation, propofol, gastrointestinal endoscopy
Brief 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 Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind. 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.
Interventions
DRUGIntralipid
Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
DRUGICI35,868 (Diprivan)
Treated by Anaesthesiologist
DRUGICI35,868 (Diprivan) + EES0000645/A (SDS)
Treated by Endoscopist with EES0000645/A(SDS)
Sponsors
Johnson & Johnson
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site) 2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year. 3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation. 4. Baseline (Visit 1) of blood oxygen saturation (SpO2)\<90% (room air) 5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achivement of Target Sedation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSSI Total Score | at 24-48 h after endoscopy | 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) |
Countries
Japan
Participant flow
Recruitment details
Of the 279 consented subjects, 7 were excluded after screening.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo administered by the anaesthesiologist without EES0000645/A | 51 |
| ICI35,868 Without EES0000645/A ICI35,868 administered by the anaesthesiologist without EES0000645/A | 101 |
| ICI35,868 With EES0000645/A ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse | 109 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | registration error, personal reason etc | 2 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A | Total |
|---|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 14.3 | 55.4 years STANDARD_DEVIATION 12.9 | 57.2 years STANDARD_DEVIATION 14.8 | 56.8 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 17 Participants | 36 Participants | 34 Participants | 87 Participants |
| Sex: Female, Male Male | 34 Participants | 65 Participants | 75 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 51 | 7 / 101 | 12 / 109 |
| serious Total, serious adverse events | 0 / 51 | 0 / 101 | 0 / 109 |
Outcome results
Primary
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.
Time frame: from scope-in to scope-out
Population: FAS (Full Analysis Set)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Achivement of Target Sedation | 21.6 % of patients |
| ICI35,868 Without EES0000645/A | Achivement of Target Sedation | 88.1 % of patients |
| ICI35,868 With EES0000645/A | Achivement of Target Sedation | 94.5 % of patients |
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
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)
Time frame: at 24-48 h after endoscopy
Population: FAS (Full Analysis Set)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PSSI Total Score | 65.3 Score on a scale (0 - 100) | Standard Deviation 19.7 |
| ICI35,868 Without EES0000645/A | PSSI Total Score | 81.2 Score on a scale (0 - 100) | Standard Deviation 12.5 |
| ICI35,868 With EES0000645/A | PSSI Total Score | 80.8 Score on a scale (0 - 100) | Standard Deviation 14.1 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA