GastroparesisNCT04474990
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
A study testing Tradipitant in people with Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 15 sites in United States.
Trial summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis, Diabetic Gastroparesis
- What is being tested?
- Tradipitant
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
- Available
Vanda Investigational Site
Boston, Massachusetts, 02215
202-734-3400
- Available
Vanda Investigational Site
Charlotte, North Carolina, 28209
202-734-3400
- Available
Vanda Investigational Site
Chesterfield, Missouri, 63005
202-734-3400
- Available
Vanda Investigational Site
Chevy Chase, Maryland, 20815
202-734-3400
- Available
Vanda Investigational Site
Houston, Texas, 77084
202-734-3400
- Available
Vanda Investigational Site
Louisville, Kentucky, 40202
202-734-3400
- Available
Vanda Investigational Site
Maitland, Florida, 32751
202-734-3400
- Available
Vanda Investigational Site
Nashville, Tennessee, 37211
202-734-3400
- Available
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104
202-734-3400
- Available
Vanda Investigational Site
Plano, Texas, 75024
202-734-3400
- Available
Vanda Investigational Site
Spokane, Washington, 99202
202-734-3400
- Available
Vanda Investigational Site
Tampa, Florida, 33613
202-734-3400
- Available
Vanda Investigational Site
Tulsa, Oklahoma, 74104
202-734-3400
- Available
Vanda Investigational Site
Wauconda, Illinois, 60084
202-734-3400
- Available
Vanda Investigational Site
Wichita, Kansas, 67214
202-734-3400
About this study
Official title: VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Read the 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:
- To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
- To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient
- Conditions
- Gastroparesis, Diabetic Gastroparesis
- Being tested
- Tradipitant
- Keywords
- gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p, expanded access
- Medical subject headings
- Gastroparesis, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TradipitantDrug
NK-1 Receptor antagonist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474990
- Sponsor's protocol ID
- VP-VLY-686-3303
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2020
- Last updated
- 24 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
- ClinicalTrials.gov ID
- NCT04474990
- Acronym / sponsor ID
- VP-VLY-686-3303
- Conditions
- Gastroparesis, Diabetic Gastroparesis
- Keywords
- gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
- To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TradipitantNK-1 Receptor antagonist | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tradipitant in people with Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals (2027343400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.