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A MULTICENTER OPEN LABEL 3 MONTH SAFETY STUDY WITH TRADIPITANT IN PATIENTS WITH IDIOPATHIC OR DIABETIC GASTROPARESIS
EU CTIS ID: 2023-503802-35-00
What this study is testing
To evaluate dosing of tradipitant on standard measures of subject safety
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female subjects aged 18 – 70 years (inclusive)
- 10. 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.
- 2. 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
- 3. Patient's gastroparesis symptoms persist despite diet and/or life-style modifications
- 4. Body Mass Index (BMI) of ≥18 and ≤ 40 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 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
You likely can't join if
- 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)
- 8. 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
- 10. Unstable cardiac, respiratory, hepatic or renal disease
- 9. Uncontrolled thyroid disease
- 11. 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)
- 12. Has a creatinine level > 2x ULN
See the full eligibility criteria
Who can join
- 1. Male and female subjects aged 18 – 70 years (inclusive)
- 10. 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.
- 2. 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
- 3. Patient's gastroparesis symptoms persist despite diet and/or life-style modifications
- 4. Body Mass Index (BMI) of ≥18 and ≤ 40 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 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
- 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
What rules you out
- 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)
- 8. 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
- 10. Unstable cardiac, respiratory, hepatic or renal disease
- 9. Uncontrolled thyroid disease
- 11. 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)
- 12. Has a creatinine level > 2x ULN
- 13. 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
- 14. Use of the following within 2 weeks of first study visit: another NK-1 antagonist or a second generation 5-HT3 antagonist
- 15. Evidence of uncontrolled blood glucose (including HbA1C >11% at screening or metabolic crisis in past 60 days)
- 16. 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)
- 17. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 1 month of the first study visit
- 18. 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);
- 2. 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.
- 3. Pregnancy or nursing
- 4. History of intolerance and/or hypersensitivity to medications similar to tradipitant and its accompanying excipients
- 5. 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)
- 6. 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
- 7. History of an eating disorder within 2 years of first study visit
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.