Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intralipid · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Intralipid | DRUG | 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) |
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 (...
Intralipid is used for sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy. It is being studied as a treatment to provide moderate sedation during these procedures, which are performed to examine the gastrointestinal tract and remove polyps.
Intralipid is a small molecule that targets the central nervous system to produce sedation. It works by depressing the central nervous system to achieve a moderate level of sedation, which is sufficient for diagnostic gastrointestinal endoscopy and endoscopic polypectomy procedures.
Intralipid is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Intralipid for sedation during gastrointestinal endoscopic procedures.
Intralipid is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is a randomized, double-blind, placebo-controlled study designed to assess its efficacy and safety for moderate sedation in gastrointestinal endoscopy.
Intralipid is being evaluated in a Phase 3 clinical trial with the identifier NCT01961349. This study, titled 'Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy,' has been completed and enrolled 279 participants in Japan. The trial was randomized, double-blind, and placebo-controlled.
Intralipid is not the same as Diprivan. The clinical trial NCT01961349 studied ICI35,868 (Diprivan) with and without EES0000645/A (SDS), which is Intralipid. Intralipid is an investigational agent being tested in combination with Diprivan for sedation during gastrointestinal endoscopy.