Idiopathic GastroparesisPhase 3NCT06836557
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
A Phase 3 study testing Tradipitant in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 3 sites in 2 countries.
Trial summary
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis
- What is being tested?
- Tradipitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Jan 2024to 30 Mar 2026
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
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
- Pregnancy or nursing
- Evidence of uncontrolled blood glucose (including HbA1C >11% at screening or metabolic crisis in past 60 days)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Vanda Investigational Site
Leuven, 3000
Vanda Investigational Site
Liège, 4000
About this study
Official title: A Multicenter, Open Label, 3-Month Safety Study With Tradipitant in Patients With Idiopathic or Diabetic Gastroparesis
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
- Being tested
- Tradipitant
- Keywords
- gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p
- 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
BID
| Study group | Role | What they receive |
|---|---|---|
| Open Label Tradipitant | Experimental | Oral Capsule Receives: Drug: Tradipitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis
Efficacy is assessed by the Gastroparesis Core Symptom Daily Diary (GCSDD). The GCSDD is a daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain.
Measured: 12 weeks
To evaluate the efficacy of tradipitant in global improvement
Efficacy is assessed by the Clinical Global Impression - Severity (CGI-S). The CGI-S is a clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start9 Jan 2024
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Vanda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836557
- Sponsor's protocol ID
- VP-VLY-686-3304
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, 3-Month Safety Study With Tradipitant in Patients With Idiopathic or Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT06836557
- Acronym / sponsor ID
- VP-VLY-686-3304
- Keywords
- gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 20 Feb 2025 (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.
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Tradipitant | Experimental | Drug: TradipitantOral Capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Key exclusion criteria (4 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
- Pregnancy or nursing
- Evidence of uncontrolled blood glucose (including HbA1C >11% at screening or metabolic crisis in past 60 days)
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 |
|---|---|---|
| TradipitantBID | Drug | Open Label Tradipitant |
Primary outcome
Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS
Time frame: 12 weeks
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.
Number of participants with changes in vital signs identified as Clinically Notable Abnormal values
Time frame: 12 weeks
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.
Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate
Time frame: 12 weeks
Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute
Number of participants with Clinically Notable Abnormal laboratory values
Time frame: 12 weeks
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.
2 secondary outcomes
To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis
Time frame: 12 weeks
To evaluate the efficacy of tradipitant in global improvement
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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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.
Vanda Pharmaceuticals study director
Vanda Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 3 sites in 2 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.