Enrolling by invitation NCT05653310
Tradipitant for Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tradipitant, Placebo.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Overview
To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.
Interventions
- Drug Tradipitant
Tradipitant Capsule - Drug Placebo
Placebo Capsule
Primary outcome measures
- Accommodation gastric volumes measured by single photon emission computed tomography (SPECT) [Time frame: 4 Weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Minnesota — Rochester
Identifiers
NCT: NCT05653310 · 21-012527