Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.
The participant is scheduled for abdominal surgery that will include at least 1 inpatient overnight stay.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will test if a drug can help improve breathing after abdominal surgery.
Who is the study for?
This trial is for adults with a BMI of 18.5-50 who have moderate obstructive sleep apnea, based on recent sleep tests or high-risk scores from questionnaires. They must be scheduled for abdominal surgery requiring an overnight stay, general anesthesia, and post-surgery opioids. Excluded are those with recent major surgeries, chemotherapy, certain infections like HIV/HCV, uncontrolled diabetes or hypertension, severe heart issues, or anticipated ICU transfer.Check my eligibility
What is being tested?
The study is testing whether Danavorexton can improve breathing in patients recovering from abdominal surgery under general anesthesia compared to a placebo. Participants will receive either the drug or placebo to assess its effectiveness in managing obstructive sleep apnea symptoms post-operation.See study design
What are the potential side effects?
While specific side effects of Danavorexton aren't listed here, common medication-related side effects could include nausea, headache, dizziness or allergic reactions. The severity and type of side effects may vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a moderate to severe physical health status according to the ASA.
Select...
I am scheduled for abdominal surgery that requires staying in the hospital overnight.
Select...
I am scheduled for surgery that will require me to be put to sleep and have a breathing tube.
Select...
I will need strong painkillers through an IV after my surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
Secondary outcome measures
Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU
Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose DanavorextonExperimental Treatment1 Intervention
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Group II: High Dose DanavorextonExperimental Treatment1 Intervention
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danavorexton
2022
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,764 Total Patients Enrolled
1 Trials studying Sleep Apnea
13 Patients Enrolled for Sleep Apnea
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,092 Total Patients Enrolled
1 Trials studying Sleep Apnea
13 Patients Enrolled for Sleep Apnea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for hepatitis B, hepatitis C, or HIV.I have a moderate to severe physical health status according to the ASA.I will need a CPAP or BiPAP machine right after surgery.I do not have uncontrolled high blood pressure or serious heart problems.I am scheduled to be moved to the ICU after surgery.I have had a severe diabetes complication in the last 6 months.You have had a sleep test in the last 5 years that showed a specific range of breathing problems while sleeping. If you haven't had a sleep test, you can still participate if you score a certain number on a questionnaire and have an at-home sleep test.I am scheduled for abdominal surgery that requires staying in the hospital overnight.I have not had chemotherapy or radiation in the last 4 weeks.I have not had major surgery or donated/lost a significant amount of blood in the last 4 weeks.I am scheduled for liver or kidney surgery.Your body mass index (BMI) is between 18.5 and 50 kg/m^2.I am scheduled for surgery that will require me to be put to sleep and have a breathing tube.Your heart's electrical activity, measured by ECG, shows a prolonged QT interval.I will need strong painkillers through an IV after my surgery.My surgery is expected to last between 1.5 to 4 hours.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose Danavorexton
- Group 2: Low Dose Danavorexton
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Apnea Patient Testimony for trial: Trial Name: NCT05814016 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals above 25 years of age being considered for involvement in this experiment?
"The age requirement for this trial is 40-75 years old, while there are an additional 40 studies available to those below 18 and 209 more options for seniors over 65."
Answered by AI
Is participation in this research project accessible at the present time?
"At present, this medical trial is not recruiting patients. It was first listed on May third of 2023 and the final update was posted April 3rd. On clinicaltrials.gov there are currently 258 other trials taking in participants though."
Answered by AI
What potential risks should patients be aware of when taking High Dose Danavorexton?
"Based on the available evidence, High Dose Danavorexton is believed to have a safety rating of 2. This estimation is based off Phase 2 trial results that suggest some degree of safety but lack efficacy data."
Answered by AI
How many healthcare institutions are currently conducting this experiment?
"This research is actively enrolling patients in Jacksonville, Florida; Miami, Massachusetts; Tampa, Missouri and 11 other sites - with Mayo Clinic Jacksonville - PPDS being the primary site. The University of Miami- Leonard M. Miller School of Medicine and University of South Florida are also participating locations."
Answered by AI
Am I permitted to join this medical experiment?
"Those with sleep apnea aged between 40 and 75 are encouraged to apply for this trial; up to 180 individuals will be selected."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Oregon
What site did they apply to?
Cedars Sinai Medical Hospital
Inspira Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I have a BiPAP and I still do not sleep very wel.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger