Tradipitant for Functional Dyspepsia

Phase 2

• Conditions: Functional Dyspepsia
• Interventions: Drug: Placebo; Drug: Tradipitant

• Registration Number: NCT05653310
• Lead Sponsor: Xiao Jing (Iris) Wang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2023-02-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Able to provide written consent
• Body Mass Index (BMI) of 18-35 kg/m2
• Absence of other diseases which could interfere with interpretation of study results

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Exclusion Criteria

• Current H. pylori infection
• Pregnancy or nursing
• Recent history of Alcohol Use Disorder or Substance Use Disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral Capsule
Tradipitant	Tradipitant	Oral Capsule

Primary Outcome Measures

Name	Time	Method
Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)	4 Weeks

Trial Locations

Locations (1)

Mayo Clinic in Minnesota; 🇺🇸 Rochester, Minnesota, United States