Tradipitant for Functional Dyspepsia

Xiao Jing (Iris) Wang

Status and phase: Invitation-only; Phase 2

Conditions: Functional Dyspepsia

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Other

Identifiers

NCT05653310

21-012527

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Description:

Oral Capsule

Treatment:

Drug: Placebo