Diabetic Gastroparesis, Gastroparesis, Idiopathic Gastroparesis
Conditions
Keywords
gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p
Brief summary
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Interventions
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD) | 12 weeks | A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary | 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) | 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) | 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) | 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) | 12 weeks | Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires. |
Countries
United States
Outcome results
None listed