Principal Investigator: John Fang
Keywords: clinical trial , tradipitant , gastroparesis Department: Gastroenterology
IRB Number: 00113161
Specialty: Gastroenterology
Sub Specialties:
Recruitment Status: Active, not recruiting

Contact Information

Jennifer Knowles
jennifer.knowles@hsc.utah.edu
8015879050

Brief Summary

Objectives:

Primary:

To evaluate the efficacy of tradipitant relative to placebo in change from baseline in

individual nausea severity scores reported daily.

Secondary:

To evaluate the efficacy of tradipitant relative to placebo in change from baseline of other

individual symptoms associated with gastroparesis

To evaluate the efficacy of tradipitant relative to placebo in change from baseline of the

overall symptom burden associated with gastroparesis

To evaluate the efficacy of tradipitant relative to placebo in change from baseline of global

improvement and quality of life measures

To explore the safety and tolerability of multiple oral doses of tradipitant.

Inclusion Criteria

1. Male and female subjects aged 18 – 70 years (inclusive);

2. Diagnosed with idiopathic or diabetic gastroparesis with moderate to severe nausea:

a. Demonstrated delayed gastric emptying of a solid meal via either scintigraphy or gastric

breath test within 10 years of screening. If solid meal is not tolerated, a liquid meal may be

used instead to demonstrate delayed gastric emptying via scintigraphy,

b. Presence of nausea symptom for at least 6 months prior to screening,

c. At least 24 screening diary entries,

d. mGCSI individual nausea score ≥ 3 at Visit 1, and

e. Average daily diary nausea severity ≥ 3 during the worst 50% days of nausea during

the screening period;

3. Patient’s gastroparesis symptoms persist despite diet and/or life-style modifications;

4. Body Mass Index (BMI) of ≥18 and ≤38 kg/m2 (BMI = weight (kg)/ [height (m)]2);

5. Subjects must agree to the following study restrictions:

a. Males of procreative capacity (not surgically sterile) will use an acceptable method of

contraception from randomization through 1 month following the last dose of study

medication. Examples of acceptable contraception for males include abstinence, use of a

barrier method, or sterilized or post-menopausal partner;

b. Females of child-bearing potential (not surgically sterile or post-menopausal, defined as 12

months without menses) will use an acceptable method of contraception from 1 month prior

to randomization (or screening, if earlier) through 1 month following the last dose of study

medication. Examples of acceptable methods of contraception for females include

abstinence, double barrier method, IUD, hormonal contraception, or sterilized partner;

6. Ability and acceptance to provide written informed consent;

7. Willing to participate in the pharmacogenomics sample collection;

8. Willing and able to comply with all study requirements and restrictions, including but not limited

to:

a. daily symptom diary completion,

b. prohibited medications, and

c. strict control of blood glucose (T1DM and T2DM patients);

9. Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria

Exclusion Criteria:

1. Another active disorder or treatment which could explain or contribute to symptoms in the

opinion of the Investigator (including but not limited to gastric malignancy, neurological

disorder, or heavy doses of strong anticholinergics);

2. Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, post-surgical cause of

gastroparesis, or gastric stimulation device surgically implanted within the last year or if

implanted more than a year ago, have changed stimulation settings within the last 3 months (ie

gastric stimulation device must have a stable setting for at least 3 months);

3. Gastric or parenteral feeding within 4 weeks of screening;

4. Pregnancy or nursing;

5. History of intolerance and/or hypersensitivity to medications similar to tradipitant and its

accompanying excipients;

6. History (including family history) or current evidence of congenital long QT syndrome or

known acquired QT interval prolongation (including QTc > 450 in males or > 470 in females at

screening);

7. History of suicide attempt and/or suicidal ideation (of type 4 or 5 on the Columbia Suicide

Severity Rating Scale (C-SSRS)) within 2 years of screening or subject is at risk of suicide at

Screening or Baseline, in the opinion of the investigator;

8. History of an eating disorder within 2 years of screening;

9. Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use

Disorder as defined in DSM-5 or evidence of such abuse which may include a positive drug

screen at the Screening visit;

10. Uncontrolled thyroid disease;

11. Unstable cardiac, respiratory, hepatic or renal disease;

12. Evidence of uncontrolled blood glucose (including HbA1C >9 or metabolic crisis in past 60

days);

13. Indication of impaired liver function (including values for AST, ALT, or bilirubin > 1.5 times

the Upper Limit of Normal, unless isolated bilirubin > 1.5 x ULN due solely to Gilbert’s

syndrome);

14. Has a creatinine level > 1.5x ULN;

15. Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or

prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable

daily dosing schedule (stable for at least 3 months prior to the screening visit) or administered

under protocol-specified rescue medication guidelines;

16. Use of the following within 2 weeks of screening: another NK-1 antagonist or a second generation

5-HT3 antagonist, phenergan more than 2 times per day, or opiods more than 2 times per week;

17. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening

Visit;

18. Exposure to any investigational medication, including placebo or domperidone, within 60 days

of the Baseline Visit;

19. Anyone affiliated with the site or sponsor and/or anyone who may consent under duress; and

20. Any other reason as determined by the Investigator which may lead to an unfavorable riskbenefit

of study participation, may interfere with study compliance, or may confound study

results.