Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
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ClinicalTrials.gov Identifier: NCT04028492 |
Recruitment Status :
Recruiting
First Posted : July 22, 2019
Last Update Posted : March 22, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis | Drug: Tradipitant Drug: Placebo Drug: Open Label Tradipitant | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 201 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 20, 2019 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Tradipitant
Oral Capsule
|
Drug: Tradipitant
BID |
Placebo Comparator: Placebo
Oral Capsule
|
Drug: Placebo
BID |
Experimental: Open Label Tradipitant
Oral Capsule
|
Drug: Open Label Tradipitant
BID |
- Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD) [ Time Frame: 12 weeks ]A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
- Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary [ Time Frame: 12 weeks ]A patient reported 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
- Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM) [ Time Frame: 12 weeks ]PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).
- Change from baseline in Patient Global Impression - Change (PGI-C) [ Time Frame: 12 weeks ]A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"
- Clinician Global Impression - Severity (CGI-S) [ Time Frame: 12 weeks ]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."
- Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) [ Time Frame: 12 weeks ]Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
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
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028492
Contact: Vanda Pharmacuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
United States, Alabama | |
Vanda Investigational Site | Recruiting |
Birmingham, Alabama, United States, 53244 | |
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Peoria, Arizona, United States, 85381 | |
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United States, Arkansas | |
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Little Rock, Arkansas, United States, 72211 | |
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United States, California | |
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Chula Vista, California, United States, 91910 | |
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La Jolla, California, United States, 92093 | |
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Los Angeles, California, United States, 90010 | |
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Los Angeles, California, United States, 90026 | |
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United States, Florida | |
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Maitland, Florida, United States, 32751 | |
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Palmetto Bay, Florida, United States, 33157 | |
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Tampa, Florida, United States, 33613 | |
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United States, Georgia | |
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Morrow, Georgia, United States, 30260 | |
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United States, Illinois | |
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Wauconda, Illinois, United States, 60084 | |
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United States, Iowa | |
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West Des Moines, Iowa, United States, 50265 | |
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United States, Kansas | |
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Wichita, Kansas, United States, 67214 | |
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United States, Kentucky | |
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Louisville, Kentucky, United States, 40202 | |
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United States, Louisiana | |
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Marrero, Louisiana, United States, 70072 | |
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United States, Maryland | |
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Chevy Chase, Maryland, United States, 20815 | |
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United States, Massachusetts | |
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Boston, Massachusetts, United States, 02114 | |
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Boston, Massachusetts, United States, 02115 | |
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United States, Missouri | |
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Chesterfield, Missouri, United States, 63005 | |
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United States, Nevada | |
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Las Vegas, Nevada, United States, 89121 | |
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United States, New York | |
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Brooklyn, New York, United States, 11201 | |
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United States, North Carolina | |
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Charlotte, North Carolina, United States, 28209 | |
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Raleigh, North Carolina, United States, 27612 | |
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United States, Ohio | |
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Columbus, Ohio, United States, 43214 | |
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Huber Heights, Ohio, United States, 45424 | |
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United States, Oklahoma | |
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Edmond, Oklahoma, United States, 73034 | |
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Tulsa, Oklahoma, United States, 74104 | |
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United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States, 19104 | |
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United States, Tennessee | |
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Chattanooga, Tennessee, United States, 37421 | |
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Nashville, Tennessee, United States, 37211 | |
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United States, Texas | |
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Houston, Texas, United States, 77043 | |
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Vanda Investigational Site | Recruiting |
Houston, Texas, United States, 77084 | |
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Plano, Texas, United States, 75024 | |
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San Antonio, Texas, United States, 78215 | |
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United States, Utah | |
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Salt Lake City, Utah, United States, 84132 | |
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Study Director: | Vanda Pharmaceuticals | Vanda Pharmaceuticals |
Documents provided by Vanda Pharmaceuticals:
Publications of Results:
Responsible Party: | Vanda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04028492 |
Other Study ID Numbers: |
VP-VLY-686-3301 |
First Posted: | July 22, 2019 Key Record Dates |
Last Update Posted: | March 22, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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