Idiopathic GastroparesisPhase 3NCT04028492
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
A Phase 3 study testing Tradipitant and Open Label Tradipitant in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 36 sites in United States.
Trial summary
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of 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 and Open Label Tradipitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 979 participants
- Where
- 36 sitesUnited States
- Study dates
- 20 Aug 2019to 21 Feb 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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;
- Exposure to any investigational medication in the past 60 days
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Vanda Investigational Site
Birmingham, Alabama, 53244
Vanda Investigational Site
Boston, Massachusetts, 02114
Vanda Investigational Site
Boston, Massachusetts, 02115
Vanda Investigational Site
Brooklyn, New York, 11201
Vanda Investigational Site
Charlotte, North Carolina, 28209
Vanda Investigational Site
Chattanooga, Tennessee, 37421
Vanda Investigational Site
Chesterfield, Missouri, 63005
Vanda Investigational Site
Chevy Chase, Maryland, 20815
Vanda Investigational Site
Chula Vista, California, 91910
Vanda Investigational Site
Columbus, Ohio, 43214
Vanda Investigational Site
Edmond, Oklahoma, 73034
Vanda Investigational Site
Houston, Texas, 77043
Vanda Investigational Site
Houston, Texas, 77084
Vanda Investigational Site
Huber Heights, Ohio, 45424
Vanda Investigational Site
La Jolla, California, 92093
Vanda Investigational Site
Las Vegas, Nevada, 89121
Vanda Investigational Site
Little Rock, Arkansas, 72211
Vanda Investigational Site
Los Angeles, California, 90010
Vanda Investigational Site
Los Angeles, California, 90026
Vanda Investigational Site
Louisville, Kentucky, 40202
Vanda Investigational Site
Maitland, Florida, 32751
Vanda Investigational Site
Marrero, Louisiana, 70072
Vanda Investigational Site
Morrow, Georgia, 30260
Vanda Investigational Site
Nashville, Tennessee, 37211
Vanda Investigational Site
Palmetto Bay, Florida, 33157
Vanda Investigational Site
Peoria, Arizona, 85381
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104
Vanda Investigational Site
Plano, Texas, 75024
Vanda Investigational Site
Raleigh, North Carolina, 27612
Vanda Investigational Site
Salt Lake City, Utah, 84132
Vanda Investigational Site
San Antonio, Texas, 78215
Vanda Investigational Site
Tampa, Florida, 33613
Vanda Investigational Site
Tulsa, Oklahoma, 74104
Vanda Investigational Site
Wauconda, Illinois, 60084
Vanda Investigational Site
West Des Moines, Iowa, 50265
Vanda Investigational Site
Wichita, Kansas, 67214
About this study
Official title: VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
- Being tested
- Tradipitant, Placebo, Open Label 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
PlaceboDrug
BID
Open Label TradipitantDrug
BID
| Study group | Role | What they receive |
|---|---|---|
| Tradipitant | Experimental | Oral Capsule Receives: Drug: Tradipitant |
| Placebo | Placebo comparator | Oral Capsule Receives: Drug: Placebo |
| Open Label Tradipitant | Experimental | Oral Capsule Receives: Drug: Open Label Tradipitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the biweekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
Measured: 12 weeks
Secondary outcomes (3)
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Total Score Using MMRM Model ITT Population
The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.
Measured: 12 Weeks
Change From Baseline to Week 12 in the Biweekly Percentage of Nausea Free Days Using MMRM Model ITT Population
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have had any nausea over the past 24 hours and if yes, to rate the worst occurrence in the past 24 hours on a Likert scale from 1 (very mild) to 5 (very severe). Change in weekly percentage of nausea-free days from baseline is calculated as biweekly average post value minus baseline value.
Measured: 12 Weeks
Change From Baseline in Overall Patient Benefit Scale (OPBS) ITT Population
The Overall Patient Benefit Scale (OPBS) is a weighted average of the recoded symptom improvement score of the five PRCGS items. The PRCGS data are recoded as follows: 3 - very much improved, 2 - much improved, 1 - minimally improved, 0 - no change or worse. The OPBS ranges from 0 to 3, with higher values indicating a better outcome.
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 posted22 Jul 2019
- Study start20 Aug 2019
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic GastroparesisStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 979 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
- NCT04028492
- Sponsor's protocol ID
- VP-VLY-686-3301
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2019
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.
PubMed 38237696
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
- ClinicalTrials.gov ID
- NCT04028492
- Acronym / sponsor ID
- VP-VLY-686-3301
- Keywords
- gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tradipitant | Experimental | Drug: TradipitantOral Capsule |
| Placebo | Placebo comparator | Drug: PlaceboOral Capsule |
| Open Label Tradipitant | Experimental | Drug: Open Label 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;
- Exposure to any investigational medication in the past 60 days
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
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 | Tradipitant |
| PlaceboBID | Drug | Placebo |
| Open Label TradipitantBID | Drug | Open Label Tradipitant |
Primary outcome
Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population
Time frame: 12 weeks
The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the biweekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
3 secondary outcomes
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Total Score Using MMRM Model ITT Population
Time frame: 12 Weeks
Change From Baseline to Week 12 in the Biweekly Percentage of Nausea Free Days Using MMRM Model ITT Population
Time frame: 12 Weeks
Change From Baseline in Overall Patient Benefit Scale (OPBS) ITT Population
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38237696Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant and Open Label Tradipitant in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Vanda Pharmaceuticals at 36 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 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028492, which also lists 1 linked publication.
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 Sep 2026.