Clinical Trials Logo
  1. Home
  2. Sleep Apnea
  3. NCT05814016

A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery

Sleep Apnea Clinical Trial

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

Clinical Trial Summary

The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.

Clinical Trial 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 undisclosed/unknown 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05814016
Study type Interventional
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Status Recruiting
Phase Phase 2
Start date May 25, 2023
Completion date March 2, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Not yet recruiting NCT06029881 - Portable System for Non-intrusive Monitoring of Sleep
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury