A MULTICENTER OPEN LABEL 3 MONTH SAFETY STUDY WITH TRADIPITANT IN PATIENTS WITH IDIOPATHIC OR DIABETIC GASTROPARESIS

Trial details

Who runs it

Vanda Pharmaceuticals Inc.

Trial code

EU 2023-503802-35-00

Record updated

1 April 2026

Original description

To evaluate dosing of tradipitant on standard measures of subject safetyRead full original descriptionShow less

To evaluate dosing of tradipitant on standard measures of subject safety

Inclusion: Male and female subjects aged 18 – 70 years (inclusive); Diagnosed with idiopathic or diabetic gastroparesis with the presence of nausea symptom: a. Atleast 24 daily diary entries b. PAGI-SYM individual nausea score ≥ 1 at Visit 1 c. The presence of atleast 2 cardinal symptoms of gastroparesis averaging greater than mild including ≥ 2 average severity in nausea, vomiting, excessive fullness, early satiety, bloating or upper abdominal pain or ≥ 1 vomiting episodes as measured by the daily symptom diary during the screening period; Diagnosed with idiopathic or diabetic gastroparesis with moderate to severe nausea: a. Demonstrated delayed gastric emptying of a solid meal via either scintigraphy, gastric breath test, or wireless motility capsule within 10 years of screening of prior study. 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 of prior study; Patient's gastroparesis symptoms persist despite diet and/or life-style modifications; Body Mass Index (BMI) of ≥18 and ≤ 40 kg/m2 (BMI = weight (kg)/ [height (m)]2); Subjects must agree to the following study restrictions:a. Males of procreative capacity (not surgically sterile) will use an acceptable method of contraception from first study visit 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 postmenopausal, defined as 12 months without menses) will use an acceptable method of contraception from 1 month prior to first study visit 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; Ability and acceptance to provide written informed consent; Willing to participate in the pharmacogenomics sample collection; 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); Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion: Use of prohibited medication or medication with anti-nausea,antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the first study visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 3 months prior to first study visit) or administered under protocol-specified rescue medication guidelines; Surgeries to the stomach including gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted in the last 2 months from screening or if gastric stimulation device surgically implanted, have changed stimulation settings within the last 1 months (ie gastric stimulation device must have a stable setting for at least 1 months); Exposure to any other investigational medication, including a placebo within 60 days of first study visit. Domperidone is allowable within the study if approved for use under national regulatory body guidelines and if taken up to recommended dosing of 10-20mg up to 4 times a day (up to 80mg per day); The inability to take the study medication; 19.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; 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); Recent history (within six months of first study visit) 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 first study visit and does not include medical marijuana use; Unstable cardiac, respiratory, hepatic or renal disease; Uncontrolled thyroid disease; History of intolerance and/or hypersensitivity to medications similar to tradipitant and its accompanying excipients; 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 first study visit or subject is at risk of suicide at first study visit, in the opinion of the investigator; History of an eating disorder within 2 years of first study visit; Indication of impaired liver function (including values for AST, ALT, or bilirubin > 2x times the Upper Limit of Normal, unless isolated bilirubin > 2 x ULN due solely to Gilbert's syndrome); Has a creatinine level > 2x ULN; Evidence of uncontrolled blood glucose (including HbA1C >11% at screening or metabolic crisis in past 60 days); 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 first study visit); Use of the following within 2 weeks of first study visit: another NK-1 antagonist or a second generation 5-HT3 antagonist; Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 1 month of the first study visit; Pregnancy or nursing.

EU CTIS 2023-503802-35-00