EUCTR2014-003250-13-PL进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis - The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Is male or female, 18 to 75 years of age, inclusive, at Screening
- •2. Willing and able to provide written, signed informed consent
- •3. Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
- •4. Composite score =2 and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
- •5. At least two of the four symptoms (ie, nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal) with a score =3 (on the GCSI-2W) at Screening
- •6. Delayed gastric emptying at Screening, defined as:
- •a. 99mTc GES: gastric emptying retention >10% at 4 hours or,
- •b. GEBT: tmax (time of maximum 13CO2 excretion rate) at 240 minutes or gastric emptying delay at 2 of 3 time points (90, 120 or 150 minutes). If a subject fails either the GES or GEBT at Screening then the subject will be allowed to perform a second gastric emptying test during the Screening Period using the GEBT in order to qualify for the study. GES or GEBT is not required if subject has had a comparable, qualifying 4-hour gastric emptying test within 1 year of Screening.
- •7. Body Mass Index (BMI) between 18 and 42 kg/m2, inclusive
- •8. Screening ECG with a QTcF in the normal range (males =450 msec and females =470 msec)
- •9. Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
- •10. Stable concomitant medications, in particular those that may affect gastroparesis symptoms, for at least 3 weeks prior to Screening. Subjects must be willing to continue these medications without changes throughout the study. Routine adjustments in daily insulin treatment are permitted.
- •11. Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for 24 hours prior to gastric emptying test during Screening, if applicable, 24 hours prior to start of the Baseline Period; during the Baseline Period
- •12. For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1. All females are considered to be of childbearing potential unless they are
- •postmenopausal (ie, amenorrheic for at least 2 years) or documented to be surgically sterile (eg, bilateral tubal ligation or total hysterectomy).
- •13. For a sexually active subject: is willing to use an acceptable method of contraception during the study and for at least 2 weeks after completion of study drug dosing
- •14. Able to communicate effectively with the investigator and comply with all study requirements, restrictions, and directions of the clinic staff.
- •Additional Inclusion Criteria for Randomization into Treatment Period: The Baseline Period can last up to 5 weeks and be no less than 7 days (the start of the Baseline Period (Visit 2) may be combined with the Screening Visit if a Screening gastric emptying test is not needed. In cases when the Baseline Period is longer than 7 days, the last consecutive 7 days prior to Day 1 will be used to determine eligibility for randomization. Subjects who meet the following additional criteria after the Baseline Period will be eligible for randomization:
- •15. GCSI-24H 7-day mean composite sc
排除标准
- •1. Have received velusetrag in a prior clinical trial
- •2. Acute severe gastroenteritis within 2 weeks prior to Screening
- •3. If Type 1 or Type 2 diabetic, a glycosylated hemoglobin(HbA1c) level >11%
- •4. History of gastric outlet obstruction
- •5. Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
- •6. History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator
- •7. Recurrent and unremitting vomiting, defined as 2 or more vomiting episodes per day for 4 or more days per week
- •8. Pronounced dehydration, in the opinion of the investigator
- •9. Hospitalization for treatment of gastroparesis or a complication of diabetes(eg, hyperglycemic coma, ketoacidosis) within 4 weeks of Screening
- •10. Concurrent eating disorder(eg, anorexia nervosa, bulimia) at Screening
- •11. Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone(TSH), hypothyroidism, or hyperthyroidism at Screening unless adequately treated.
- •12. Known secondary causes of gastroparesis, including but not limited to Parkinson's Disease, cancer, viral illness, or connective tissue diseases.
- •13. Subject is unwilling to abstain from nicotine-containing products(eg. cigarettes, chewing tabacco, nicotine-containing gum) and/or alcohol on the morning of and throughout testing on the day of a gastric emptying
- •test, if applicable.
- •14. Subject is unwilling or unable to perform gastric emptying test, if applicable(eg, allergic to eggs, gluten, lactose or Spirulina)
- •15. Aspartate aminotransferase(AST), alanine transaminase(ALT) levels >2 times the upper limit of Normal at Screening;bilirubin, alkaline phosphatase(ALP), or creatinine levels >1.5 times the upper limit of normal; or hemoglobin <10 g/dL at Screening
- •16. Use of a prohibited medication, including but not limited to, opioids(eg. for chronic pain), linaclotide, or lubiprostone within 2 weeks prior to Screening and throughout the duration of the study
- •17. Received strong CYP3A4 inhibitors(eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, grapefruit juice) or strong CYP3A4 inducers(eg, rifampin, rifabutin, rifapentin, dexamethasone, phenytoin,carbamazepine, phenobarbital, St. John's wort) within 2 weeks prior to Screening and throughout the duration of the study.
- •18. Received strong P-glycoprotein(P-gp) transporter inhibitors(eg, ritonavir, cyclosporine) within 2 weeks prior to Screening and throughout the duration of the study
- •19. Active treatment for cancer or malignancy(other than nonmelanomatous skin cancer) within 1 year prior to Screening
- •20. Participation in an investigational study, involving an investigational drug, within 30 days prior to Screening or approximately five half-lives of the investigational drug if half-life is known, whichever occurs later, or has need of any investigational agent before completion of all scheduled study evaluations
- •21. Presence of disease states that would affect safety and efficacy evaluation, such as cardiovascular disease (eg, acute coronary syndrome, acute myocardial infarction or life-threatening tachyarrhythmia within 3 months prior to Screening), respiratory (eg, requires oxygen), hepatic(eg, cirrhosis, or evidenc
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