Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814016
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-04-03
Brief Title:
A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Efficacy Pharmacokinetics and Pharmacodynamics of a Single Intravenous Infusion of Danavorexton in Participants With Moderate to Severe Obstructive Sleep Apnea Undergoing General Anesthesia for Abdominal Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim is to see if danavorexton can help improve peoples breathing in the recovery room after abdominal surgery
Detailed Description:
The drug being tested in this study is called danavorexton Danavorexton is being tested in people who have moderate to severe obstructive sleep apnea undergoing general anesthesia for abdominal surgery
The study will enroll approximately 180 participants Participants will be randomly assigned by chance like flipping a coin to one of the three groups-which will remain undisclosedunknown to the participant and study doctor during the study unless there is an urgent medical need
Danavorexton high dose
Danavorexton low dose
Placebo All participants will receive an intravenous IV infusion on Day 1 of the treatment period
This multi-center study will be conducted in approximately 20 sites in the United States The overall time for participants to participate in the study will be up to approximately 12 months
The study will enroll approximately 180 participants Participants will be randomly assigned by chance like flipping a coin to one of the three groups-which will remain undisclosedunknown to the participant and study doctor during the study unless there is an urgent medical need
Danavorexton high dose
Danavorexton low dose
Placebo All participants will receive an intravenous IV infusion on Day 1 of the treatment period
This multi-center study will be conducted in approximately 20 sites in the United States The overall time for participants to participate in the study will be up to approximately 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None