Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
NCT ID: NCT06836557
Last Updated: 2025-02-20
Study Results
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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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2024-01-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label Tradipitant
Oral Capsule
Tradipitant
BID
Interventions
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Tradipitant
BID
Eligibility Criteria
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Inclusion Criteria
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Vanda Pharmaceuticals
Role: STUDY_DIRECTOR
Vanda Pharmaceuticals
Locations
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Vanda Investigational Site
Leuven, , Belgium
Vanda Investigational Site
Liège, , Belgium
Vanda Investigational Site
Leipzig, , Germany
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Other Identifiers
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VP-VLY-686-3304
Identifier Type: -
Identifier Source: org_study_id
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