A Phase 3 interventional study of Intralipid and ICI35,868 (Diprivan) in Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy, sponsored by AstraZeneca. Completed at 3 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-11-27.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Group 1 (placebo group) is treated by Anaesthesiologist
Drug: Intralipid
Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
Drug: ICI35,868 (Diprivan)
Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)
Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
Treated by Anaesthesiologist
Treated by Endoscopist with EES0000645/A(SDS)
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
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
Of the 279 consented subjects, 7 were excluded after screening.
| Milestone | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A |
|---|---|---|---|
| Started | 54 | 107 | 111 |
| Completed | 51 | 101 | 109 |
| Not completed | 3 | 6 | 2 |
| Withdrew: Withdrawal by subject | 1 | 4 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Registration error, personal reason etc | 2 | 2 | 1 |
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)
| Score on a scale (0 - 100) | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A |
|---|---|---|---|
| PSSI Total Score | 65.3 ± 19.7 | 81.2 ± 12.5 | 80.8 ± 14.1 |
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.
| % of patients | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A |
|---|---|---|---|
| Achivement of Target Sedation | 21.6 (11.3 to 35.3) | 88.1 (80.2 to 93.7) | 94.5 (88.4 to 98.0) |
Collected over 3 days. Non-serious events are listed at a 1.8% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/51 (0%) | 9/51 (17.6%) |
| ICI35,868 Without EES0000645/A | — | 0/101 (0%) | 7/101 (6.9%) |
| ICI35,868 With EES0000645/A | — | 0/109 (0%) | 12/109 (11%) |
| Event | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A |
|---|---|---|---|
| Abdominal pain lowerGastrointestinal disorders | 5/51 | 1/101 | 2/109 |
| Abdominal distensionGastrointestinal disorders | 2/51 | 1/101 | 0/109 |
| blood urine presentInvestigations | 1/51 | 2/101 | 3/109 |
| sedationNervous system disorders | 0/51 | 1/101 | 3/109 |
| disinhibitionPsychiatric disorders | 0/51 | 2/101 | 2/109 |
| oxygen saturation decreasedInvestigations | 1/51 | 0/101 | 2/109 |
| Age, Continuous(years) | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A | Total |
|---|---|---|---|---|
| Mean | 58.6 ± 14.3 | 55.4 ± 12.9 | 57.2 ± 14.8 | 56.8 ± 14.0 |
| Sex: Female, Male(Participants) | Placebo | ICI35,868 Without EES0000645/A | ICI35,868 With EES0000645/A | Total |
|---|---|---|---|---|
| Female | 17 | 36 | 34 | 87 |
| Male | 34 | 65 | 75 | 174 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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