Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

NCT06836557 | Recruiting Phase 3 FDA Drug

• 1 other identifier: VP-VLY-686-3304
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

Conditions

Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis

Keywords

gastroparesis; idiopathic; diabetic; tradipitant; nausea; vomiting; stomach; motility; functional; NK-1 antagonist; neurokinin 1 receptor; substance p

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS

  AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides.

  12 weeks

• Number of participants with changes in vital signs identified as Clinically Notable Abnormal values

  Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable.

  12 weeks

• Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate

  Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute

  12 weeks

• Number of participants with Clinically Notable Abnormal laboratory values

  Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products.

  12 weeks

Secondary Outcomes (2)

• To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis

  12 weeks

• To evaluate the efficacy of tradipitant in global improvement

  12 weeks

Study Arms (1)

Open Label Tradipitant

EXPERIMENTAL

Oral Capsule

Drug: Tradipitant

Interventions

Tradipitant DRUG

BID

Open Label Tradipitant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with gastroparesis
• Demonstrated delayed gastric emptying
• Presence of moderate to severe nausea
• Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

You may not qualify if:

• Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
• A positive test for drugs of abuse at the screening or evaluation visits
• Pregnancy or nursing
• Evidence of uncontrolled blood glucose (including HbA1C \>11% at screening or metabolic crisis in past 60 days)

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (3)

Vanda Investigational Site

Leuven, 3000, Belgium

RECRUITING

Vanda Investigational Site

Liège, 4000, Belgium

RECRUITING

Vanda Investigational Site

Leipzig, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Vanda Pharmaceuticals

  Vanda Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Vanda Pharmaceuticals

CONTACT

202-734-3400; clinicaltrials@vandapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: February 20, 2025
• Study Start: January 9, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); DE (1)