Tradipitant for Indigestion

Recruiting 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.

Will I have to stop taking my current medications?

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

What makes the drug Tradipitant unique for treating indigestion?

Tradipitant is unique because it targets a different mechanism than traditional treatments for indigestion, focusing on the neurokinin-1 (NK1) receptor, which is involved in regulating nausea and vomiting, rather than the acid production targeted by common treatments like proton pump inhibitors (PPIs). ^{1 2 3 4 5}

Research Team

Xiao Jing (Iris) Wang, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A comparative pharmacodynamic study of IY-81149 versus omeprazole in patients with gastroesophageal reflux disease. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of on-demand therapy using 20-mg vonoprazan for non-erosive reflux disease. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Irsogladine maleate and rabeprazole in non-erosive reflux disease: A double-blind, placebo-controlled study. [2018]