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 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis||Drug: Tradipitant Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||September 2021|
|Estimated Study Completion Date :||September 2021|
Placebo Comparator: Placebo
- 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.
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 Pharmacuticalsemail@example.com|
|Study Director:||Vanda Pharmaceuticals||Vanda Pharmaceuticals|