EUCTR2014-005623-27-BE进行中（未招募）1 期
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 395
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. T1DM or T2DM with stable glycemic control and HbA1c =11% at screening.
- •2. DG, defined as at least a 3-month history of symptoms suggestive of gastroparesis on an ongoing basis (e.g., vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain).
- •3. GCSI-DD score =2.6 at least once during the Screening Period (Visits 1-2).
- •4. At least 2 vomiting episodes during the ~2 weeks prior to the first screening visit (Visit 1), as ascertained by patient history.
- •5. Delayed GE confirmed at screening by abnormal GEBT (AB Diagnostics), defined as GE half-time (t1/2) =79 minutes (the 80th percentile of normative data). At least 50% of patients enrolled will have a t1/2 =97 minutes (i.e., the 95th percentile).
- •6. Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to Visit 2 (daily adjustments of insulin doses are permitted).
- •7. No use of metoclopramide, erythromycin, domperidone, or other GI motility agents, or anti-emetics for at least 2 weeks prior to Visit 2, and willingness to remain off these medications (except as used as part of protocol specific rescue medication) during the course of the clinical trial.
- •8. Body mass index >18 kg/m2.
- •9. If female, has a negative serum or urine pregnancy test and is not lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female patients unable to bear children must have this documented in the eCRF (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of 1 year since
- •the last menstrual period]). Post-menopausal status will be confirmed by measurement of follicle stimulating hormone (FSH).
- •10. Able to provide written informed consent prior to any study procedures and willing and able to comply with study procedures.
- •Additional inclusion criteria for randomization after the 2-week single-blind placebo run-in period:
- •11. Compliance with the completion of the DGSSD and study drug injections, defined as approximately 80% diary completions and approximately 80% administration of injections, during the 2-week single-blind placebo run-in period. For those patients whose compliance is measured to be <80%, the final decision to randomize a patient will be made by the Investigator and the Sponsor (or designee).
- •12. At least one vomiting episode at any time during the 2-week single-blind placebo run-in period, as recorded in the DGSSD.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression.
- •2. History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure. (A history of diagnostic endoscopy is not exclusionary.)
- •3. History of pyloric injection of botulinum toxin within 6 months of screening.
- •4. Patients with clinical suspicion of upper GI obstruction (e.g., peptic stricture) must have been evaluated per standard of care and obstruction ruled out before screening.
- •5. Currently taking opiates, or expecting to use opiates during the course of the clinical trial.
- •6. Currently taking GLP-1 agonists, SGLT2 inhibitors or pramlintide.
- •7. Allergic or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal. (Gluten-free crackers can be provided.)
- •8. History of anorexia nervosa, binge-eating, or bulimia within 5 years of screening.
- •9. ALT or AST > 2 × upper limit of normal (ULN) at Visit 1.
- •10. History of intestinal malabsorption or pancreatic exocrine disease.
- •11. Requires hemodialysis or has end-stage renal disease.
- •12. History of human immunodeficiency virus (HIV) infection.
- •13. Clinically significant neurologic or psychiatric disorders that are likely to impact compliance with protocol requirements.
- •14. Poor venous access or inability to tolerate venipuncture.
- •15. Participation in a clinical study within the 30 days prior to dosing in the present study.
- •16. Any other reason that, in the Investigator’s opinion, would confound proper interpretation of the study or expose a patient to unacceptable risk, including renal, hepatic or cardiopulmonary disease, or significant acute ECG abnormalities.
研究者
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