NCT04474990AvailableNot Applicable
VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Sponsor
- Vanda Pharmaceuticals
- Locations
- 1
Study Overview
Brief Summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Detailed Description
This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.
Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.
Primary Objective:
-To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Secondary Objectives:
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Identified subject who requested expanded access
- •Diagnosed with gastroparesis
- •Demonstrated delayed gastric emptying
- •Presence of moderate to severe nausea
- •Patient does not qualify for or does not have access to other clinical trials with tradipitant;
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;
- •Exposure to any investigational medication in the past 60 days other than tradipitant
- •Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
- •Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
Investigators
Study Sites (1)
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