Last updated on December 2019

A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetic Gastroparesis | Idiopathic Gastroparesis
  • Age: Between 18 - 85 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Should have experienced symptoms of gastroparesis (e.g., postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety for at least 3 months before screening as assessed by a physician.
  2. Should have confirmed delayed gastric emptying at Screening; delayed gastric emptying by gastric emptying breath test (GEBT) is defined as t1/2 79 minutes (80th percentile).
  3. Must have an average composite ANMS GCSI-DD symptom score 2 during the 7 days before randomization. The predominant symptom experienced by participants must not be abdominal pain.
  4. Must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score 2 at least 4 of 7 days or an average nausea subscale symptom score 2 during the 7 days before randomization. Nausea symptoms must not be attributable to a central disorder (e.g. motion sickness, glaucoma, menstrual cycles, migraine headache).
  5. Has a body mass index (BMI) of 19 to 40 kg/m^2 inclusive
  6. Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) 11% at screening and before randomization.

Exclusion Criteria:

  1. Known secondary causes of gastroparesis including but not limited to Parkinson disease, cancer, viral illness, or connective tissue diseases.
  2. Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain associated with bowel movement.
  3. Is taking medications that affect gastric emptying including opioids, glucagon-like peptide-1 analogs (e.g., exenatide, liraglutide), amylin analogs (e.g., pramlintide), and cannabinoids.
  4. Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, bariatric surgery, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach.
  5. History of intra-pyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator.
  6. Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks before the Screening Visit.
  7. Required parenteral nutrition for treatment of gastroparesis within 2 months before the Screening Visit.
  8. Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
  9. Poor control of diabetes within 30 days prior to randomization, including diabetic ketoacidosis, hypoglycemia requiring medical intervention, admission for control of diabetes or diabetic complications
  10. Elevated serum prolactin (>upper limit of normal [ULN]) at Screening Visit 2.
  11. Has concurrent hypogonadism, current clinically significant menstrual abnormalities, such as amenorrhea or oligomenorrhea, or other clinical features of hyperprolactinemia such as galactorrhea or gynecomastia.
  12. Uncontrolled or poorly controlled medical or psychiatric comorbidities which might affect their ability to participate in the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.