Tradipitant for Indigestion

Enrolling by invitation at 1 trial location

Overseen By Vanda Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Xiao Jing (Iris) Wang

Disqualifiers: H. pylori infection, Pregnancy, Alcohol use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called tradipitant to determine its effectiveness for people with functional dyspepsia, a type of indigestion causing stomach discomfort. Researchers compare tradipitant to a placebo to assess improvements in stomach function and reductions in feelings of fullness and discomfort after eating. The trial seeks individuals with ongoing indigestion who do not have other diseases that might affect the results. Participants should have a BMI between 18 and 35 and be free of conditions like H. pylori infection. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that tradipitant is likely to be safe for humans?

Research has shown that tradipitant is generally safe for use. Studies have found that patients with gastroparesis, a stomach disorder that slows or stops food from moving to the small intestine, tolerate tradipitant well. In these studies, tradipitant reduced symptoms like nausea and vomiting without causing serious side effects. Additionally, the studies confirmed its safety over a 12-week period, reinforcing its reputation as a well-tolerated option. While specific side effects were not detailed, consistent results from multiple studies support its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for indigestion, like antacids, H2 blockers, and proton pump inhibitors, work by reducing stomach acid or neutralizing it. But Tradipitant stands out because it targets a different pathway. It works by blocking the neurokinin-1 (NK1) receptor, which is thought to play a role in the sensation of nausea and discomfort. Researchers are excited about Tradipitant because it offers a novel mechanism of action that may address symptoms in patients who do not respond well to traditional acid-reducing therapies. This could mean a significant improvement in quality of life for those with persistent indigestion.

What evidence suggests that tradipitant might be an effective treatment for indigestion?

Research has shown that tradipitant, which participants in this trial may receive, may help with symptoms like nausea and stomach discomfort. In previous studies, people taking tradipitant reported fewer and less severe nausea symptoms, especially in conditions like gastroparesis, which resembles indigestion. Tradipitant blocks a part of the brain that causes nausea and vomiting, which might explain its effectiveness. In some studies, people felt better as soon as two weeks after starting the treatment. Tradipitant improved overall stomach symptoms compared to a placebo, making it a promising option for those with functional dyspepsia. ^{1 3 5 6 7}

Who Is on the Research Team?

Xiao Jing (Iris) Wang, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 18-35 who suffer from functional dyspepsia, commonly known as indigestion. Participants must be able to consent and not have other conditions that could affect the study's results. Those with recent alcohol or substance use disorders, current H. pylori infection, or who are pregnant or nursing cannot join.

Inclusion Criteria

Body Mass Index (BMI) of 18-35 kg/m2

Able to provide written consent

I don't have other health conditions that could affect the study's outcome.

Exclusion Criteria

Current H. pylori infection

Pregnancy or nursing

Recent history of Alcohol Use Disorder or Substance Use Disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tradipitant or placebo to evaluate effects on gastric motor functions, satiation, and postprandial symptoms

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tradipitant

Trial Overview The trial is testing Tradipitant against a placebo to see if it improves gastric functions and reduces symptoms like feeling full quickly (satiation) and discomfort after eating in people with indigestion.

How Is the Trial Designed?

Group I: Tradipitant Experimental Treatment 1 Intervention

Oral Capsule

Group II: Placebo Placebo Group 1 Intervention

Oral Capsule

Who Is Running the Clinical Trial?

Xiao Jing (Iris) Wang

Lead Sponsor

Trials

1

Recruited

60+

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

On-demand therapy using 20-mg vonoprazan for 8 weeks in 30 patients with non-erosive reflux disease showed similar effectiveness to continuous proton pump inhibitor (PPI) maintenance therapy, as patient satisfaction and symptom scores remained unchanged.

The study found that patients took a median of 11 tablets during the 8-week period, with 30% using vonoprazan regularly, indicating that on-demand therapy can be a practical alternative for managing reflux symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of on-demand therapy using 20-mg vonoprazan for non-erosive reflux disease. Hoshikawa, Y., Kawami, N., Hoshino, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02970968

NCT02970968 | Study to Assess the Efficacy of VLY-686 in ... The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1542356524000508

The Efficacy of Tradipitant in Patients With Diabetic and ... Tradipitant, a NK1R antagonist, has demonstrated promising efficacy in improving nausea and other symptoms associated with gastroparesis. In a 4-week phase 2 ...

3. journals.lww.com journals.lww.com/ajg/fulltext/2022/10002/s1592_efficacy_analysis_of_tradipitant_in.1592.aspx

S1592 Efficacy Analysis of Tradipitant in Idiopathic and... Tradipitant treatment in the BSI analysis subpopulation resulted in improvements in Nausea, PGI-C, and OPB Score both the earliest (Week 2) and last (Week 12) ...

4. gastrojournal.org gastrojournal.org/article/S0016-5085(20)34958-1/fulltext

Efficacy and Safety of Tradipitant in Patients With Diabetic ... Tradipitant reduced nausea and vomiting and improved measures of overall gastroparesis symptoms compared to placebo. Limitations. Studies are ...

5. vandapharmaceuticalsinc.gcs-web.com vandapharmaceuticalsinc.gcs-web.com/node/14786/pdf

Vanda Pharmaceuticals Reports Results from the Phase III ... Both treatment arms showed significant improvements from baseline on nausea as well as the other core symptoms of gastroparesis. Initial ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0016508520349581

Efficacy and Safety of Tradipitant in Patients With Diabetic ... Tradipitant reduced nausea and vomiting and improved measures of overall gastroparesis symptoms compared to placebo.

7. cghjournal.org cghjournal.org/article/S1542-3565(24)00050-8/fulltext

The Efficacy of Tradipitant in Patients With Diabetic ... In this study, tradipitant was shown to be safe in patients with idiopathic or diabetic gastroparesis. Tradipitant and other NK1R agonists have ...