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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Group 1 (placebo group) is treated by Anaesthesiologist |
|
| Group 2 | Active Comparator | Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist |
|
| Group 3 | Active Comparator | Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid | Drug | Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from scope-in to scope-out |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 24-48 h after endoscopy |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Moriya-shi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| D0092C00002\_CSR\_Synopsis.pdf | View source |
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Of the 279 consented subjects, 7 were excluded after screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered by the anaesthesiologist without EES0000645/A |
| FG001 | ICI35,868 Without EES0000645/A | ICI35,868 administered by the anaesthesiologist without EES0000645/A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ICI35,868 (Diprivan) | Drug | Treated by Anaesthesiologist |
|
| ICI35,868 (Diprivan) + EES0000645/A (SDS) | Drug | Treated by Endoscopist with EES0000645/A(SDS) |
|
| Shinjuku-ku |
| Japan |
| Research Site | Yokohama | Japan |
| FG002 | ICI35,868 With EES0000645/A | ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered by the anaesthesiologist without EES0000645/A |
| BG001 | ICI35,868 Without EES0000645/A | ICI35,868 administered by the anaesthesiologist without EES0000645/A |
| BG002 | ICI35,868 With EES0000645/A | ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | FAS (Full Analysis Set) | Posted | Mean | Standard Deviation | Score on a scale (0 - 100) | at 24-48 h after endoscopy |
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| 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. | FAS (Full Analysis Set) | Posted | Number | 95% Confidence Interval | % of patients | from scope-in to scope-out |
|
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo administered by the anaesthesiologist without EES0000645/A | 0 | 51 | 9 | 51 | ||
| EG001 | ICI35,868 Without EES0000645/A | ICI35,868 administered by the anaesthesiologist without EES0000645/A | 0 | 101 | 7 | 101 | ||
| EG002 | ICI35,868 With EES0000645/A | ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse | 0 | 109 | 12 | 109 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| disinhibition | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| blood urine present | Investigations | MedDRA | Non-systematic Assessment |
| |
| sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| oxygen saturation decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hideo Negi | CO RI&A TA, R&D | +81 6 4803 3533 | 4716 | H.Negi@astrazeneca.com |
| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| No |
| Superiority or Other |
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