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Tradipitant for Gastroparesis

Phase 3
Recruiting
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing whether tradipitant can relieve symptoms of gastroparesis better than placebo.

Eligible Conditions
  • Gastroparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
Secondary outcome measures
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
Change from baseline in Patient Global Impression - Change (PGI-C)
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 27 Patients • NCT04849559
15%
fatigue
15%
somnolence
8%
peripheral swelling
8%
diarrhea
8%
Acne
8%
headache
8%
disturbance in attention
8%
dizziness postural
8%
restless leg syndrome
8%
depressed mood
8%
libido decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tradipitant
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TradipitantExperimental Treatment1 Intervention
Oral Capsule
Group II: PlaceboPlacebo Group1 Intervention
Oral Capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,154 Total Patients Enrolled
2 Trials studying Gastroparesis
150 Patients Enrolled for Gastroparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research projects have been conducted utilizing Tradipitant?

"Initially trialed in 2019 at Vanda Investigational Site, tradipitant has seen 19478 studies completed to date. At present there is one active trial occurring primarily out of Raleigh, North carolina."

Answered by AI

Is enrollment in this medical research project open to the public?

"Those hoping to join the clinical trial must have gastroparesis, as well as meet the age requirement of 18-70. A total of 250 participants are accepted into this study."

Answered by AI

What potential hazards does Tradipitant pose to patients?

"Our team has assigned Tradipitant a score of 3, signifying that safety data from multiple iterations have confirmed its efficacy."

Answered by AI

Does this clinical trial still need participants?

"Unfortunately, the trial is no longer open to new patients. It was initially published on August 20th 2019 and last updated on March 2nd 2021. However, 38 trails for gastroparesis are still recruiting as well as one study utilizing Tradipitant."

Answered by AI

What is the present scope of this clinical trial?

"42 medical centres across America are currently hosting this trial. Three of these sites can be found in Raleigh, Tulsa and Nashville with the rest spread out throughout the country. To reduce any travel-based inconvenience, it is recommended that participants select a site closest to their area of residence."

Answered by AI

Is this an unprecedented clinical trial?

"Currently, Tradipitant is the subject of only one active study across 48 cities and 1 country. This endeavor was initiated in 2019 by Vanda Pharmaceuticals with 250 participants that successfully completed Phase 3 of drug approval. Since then, 19,478 trials have been conducted."

Answered by AI

What is the upper limit of participants included in this research endeavor?

"Unfortunately, this clinical trial has ceased recruitment. It was first announced on August 20th 2019 and last updated on March 2nd 2021. If you are interested in similar trials of study, currently 38 gastroparesis studies and 1 Tradipitant research project require participants."

Answered by AI

Is there an age cut-off for individuals to be considered as participants in this research endeavor?

"To be considered for this experiment, applicants must fall within the age range of 18 to 70. Additionally, there are 5 trials specifically recruiting minors and 36 studies that prioritize individuals aged 65 or above."

Answered by AI

Who else is applying?

What state do they live in?
Utah
California
How old are they?
65+
18 - 65
What site did they apply to?
Vanda Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Vanda Investigational Site: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
2019. "Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04028492.
All > Diabetic Gastroparesis > Gastroparesis
~44 spots leftby Apr 2025
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