Tradipitant for Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Tradipitant, a potential treatment for nausea and vomiting caused by certain weight-loss medications in adults who are overweight or have mild obesity. Participants will receive either Tradipitant or a placebo (inactive treatment) for about two weeks. Eligible participants should have no serious health issues, no diabetes, and no history of problems with similar medications. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have been on any investigational medication in the past 60 days, you cannot participate.
Is there any evidence suggesting that Tradipitant is likely to be safe for humans?
Research has shown that tradipitant is generally safe. In earlier studies, participants taking tradipitant did not report any new safety issues. The drug was usually well-tolerated, with fewer cases of severe nausea and vomiting compared to those taking a placebo. For example, only 13.3% of participants taking tradipitant experienced severe symptoms, while 33% of those on a placebo did.
Additionally, people with diabetic and idiopathic gastroparesis (a stomach condition that affects digestion) have used tradipitant safely. This suggests it might be safe for other groups as well. However, the FDA has indicated that more information might be needed for certain conditions. Overall, tradipitant appears safe based on current evidence.12345Why do researchers think this study treatment might be promising?
Tradipitant is unique because it targets the neurokinin-1 receptor, which is a different mechanism than most current treatments for nausea and vomiting, like antihistamines and serotonin antagonists. This new approach could offer relief for patients who do not respond well to existing medications. Researchers are excited about tradipitant because it has the potential to effectively reduce symptoms faster, potentially improving the quality of life for those suffering from persistent nausea and vomiting.
What evidence suggests that Tradipitant might be an effective treatment for nausea and vomiting?
Research has shown that tradipitant can help reduce nausea and vomiting. In studies, participants taking tradipitant experienced less severe symptoms compared to those taking a placebo (a pill with no active medicine). For instance, one study found that only 18% of people on tradipitant had severe symptoms, while 38% of those on placebo did. This trial will compare the effects of tradipitant with a placebo over approximately two weeks. These findings suggest that tradipitant could be promising for managing nausea and vomiting in various situations.34567
Who Is on the Research Team?
Vanda Pharmaceuticals Inc.
Principal Investigator
Vanda Pharmaceuticals Inc.
Are You a Good Fit for This Trial?
This trial is for adults who are overweight or have class I or II obesity (BMI between 25 and 40), do not have diabetes, and are experiencing nausea or vomiting from GLP-1R agonist medications. Participants should not have serious health problems, certain gut disorders, or allergies to the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either tradipitant or placebo BID for approximately 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tradipitant
Trial Overview
The study compares Tradipitant with a placebo to see if it helps reduce nausea and vomiting caused by GLP-1R agonists in overweight or obese adults. Participants are randomly assigned to one of two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Treatment with tradipitant BID for approximately 2 weeks
Treatment with placebo BID for approximately 2 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor
Citations
tradipitant effective in the treatment of motion sickness
Tradipitant prevented severe nausea and vomiting as compared to participants taking placebo (tradipitant = 18.03%, placebo = 37.70%, p < 0.0001) ...
Vanda Pharmaceuticals Reports Positive Results for ...
The study also met the key secondary endpoint of the proportion of participants with vomiting and significant nausea at 22.4% in the tradipitant ...
Vanda Pharmaceuticals Reports Results from a Phase III ...
Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 18.3% and 19.5% of participants.
Tradipitant Effective in the Reduction of Vomiting ...
Participants on tradipitant 170 mg or 85 mg had a significantly lower incidence of vomiting as compared to those on placebo across all boat ...
The Efficacy of Tradipitant in Patients With Diabetic ...
In these analyses, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea at week 12. A ...
NEREUS (tradipitant) - accessdata.fda.gov
Use the lowest effective dose. The safety of NEREUS for the prevention of vomiting induced by motion in adults for more than 90 doses has not been established ...
Efficacy and Safety of Tradipitant in Patients With Diabetic ...
Results: Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction ...
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