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NCT05653310 Clinical Trial

Tradipitant for Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05653310
Other study ID # 21-012527
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date February 9, 2023
Est. completion date December 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Exclusion Criteria: - Current H. pylori infection - Pregnancy or nursing - Recent history of Alcohol Use Disorder or Substance Use Disorder

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant
Tradipitant Capsule
• Placebo
Placebo Capsule

Locations
Country Name City State
United States Mayo Clinic in Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Xiao Jing (Iris) Wang Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accommodation gastric volumes measured by single photon emission computed tomography (SPECT) 4 Weeks
See also
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Completed NCT01671670 - Acupuncture for Patients With Function Dyspepsia Phase 2/Phase 3
Completed NCT00987805 - Efficacy of Banhasasim-tang on Functional Dyspepsia Phase 4
Completed NCT00761358 - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia Phase 3
Completed NCT00693407 - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation N/A
Recruiting NCT01240096 - Mirtazapine Versus Placebo in Functional Dyspepsia Phase 4
Recruiting NCT04540549 - Effects of Exercise on Functional Dyspepsia Based on Rome IV N/A
Recruiting NCT03652571 - Nortriptyline for the Treatment of Functional Dyspepsia Phase 3
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Not yet recruiting NCT04548011 - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia N/A
Terminated NCT02567578 - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia Phase 2
Completed NCT03007433 - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging N/A
Active, not recruiting NCT00990405 - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia Phase 4
Completed NCT00404534 - Helicobacter Eradication Relief of Dyspeptic Symptoms Phase 3
Completed NCT03043625 - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia N/A
Completed NCT03225248 - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia Phase 3
Recruiting NCT05587127 - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia N/A
Recruiting NCT01021475 - Does Visceral Manipulation Works in Treating Functional Dyspepsia? Phase 1