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
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
Interventions
DRUGTradipitant
BID
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 * Pregnancy or nursing * Evidence of uncontrolled blood glucose (including HbA1C \>11% at screening or metabolic crisis in past 60 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS | 12 weeks | AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides. |
| Number of participants with changes in vital signs identified as Clinically Notable Abnormal values | 12 weeks | Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable. |
| Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate | 12 weeks | Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute |
| Number of participants with Clinically Notable Abnormal laboratory values | 12 weeks | Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis | 12 weeks | Efficacy is assessed by the Gastroparesis Core Symptom Daily Diary (GCSDD). The GCSDD is a 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. |
| To evaluate the efficacy of tradipitant in global improvement | 12 weeks | Efficacy is assessed by the Clinical Global Impression - Severity (CGI-S). The CGI-S is 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. |
Countries
Belgium, Germany
Contacts
Primary ContactVanda Pharmaceuticals
Outcome results
None listed