Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

NCT ID: NCT06836557

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Tradipitant

Oral Capsule

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

BID

Interventions

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Tradipitant

BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanda Pharmaceuticals

Role: STUDY_DIRECTOR

Vanda Pharmaceuticals

Locations

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Vanda Investigational Site

Leuven, , Belgium

Site Status RECRUITING

Vanda Investigational Site

Liège, , Belgium

Site Status RECRUITING

Vanda Investigational Site

Leipzig, , Germany

Site Status RECRUITING

Countries

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Belgium Germany

Central Contacts

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Vanda Pharmaceuticals

Role: CONTACT

202-734-3400

Facility Contacts

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Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Other Identifiers

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VP-VLY-686-3304

Identifier Type: -

Identifier Source: org_study_id

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