Buspirone for Early Satiety and Symptoms of Gastroparesis

Inclusion Criteria

• Age 18 to 85 years of age at initial screening interview
• Symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview
• Diagnosis of either diabetic or idiopathic gastroparesis
• Delayed or normal gastric emptying retention on screening 4-hour Gastric Emptying Scintigraphy test
• Symptoms of gastroparesis measured by the 9-item PAGI-SYM Gastroparesis Cardinal Symptom Index (GCSI) total score > 2.0 at enrollment
• Symptomatic with postprandial fullness/early satiety severity at enrollment using the PAGI-SYM GCSI post-prandial fullness/early satiety subscore ≥ 3
• Upper endoscopy or upper GI series without ulcers or mass lesions in the 2 years prior to enrollment

Exclusion Criteria

• Post-surgical gastroparesis, including prior pyloromyotomy, pyloric resection, vagotomy, bariatric surgery or post-Nissen fundoplication
• Another active disorder which could explain symptoms in the opinion of the investigator
• Concurrent use of opiate narcotic analgesics more than 3 days per week
• Significant hepatic injury as defined by alanine aminotransferase (ALT) elevation of greater than twice the Upper Limit of Normal (ULN) or a Child-Pugh score of 10 or greater
• Significant renal impairment as defined by serum creatinine > 3.0
• Uncontrolled diabetes defined as HbA1c (%) of 10% or more within 60 days of enrollment
• Allergy to buspirone
• Concurrent or prior use (within 30 days) of monoamine oxidase (MAO) inhibitors
• Concurrent or prior use (within 30 days) of benzodiazepines
• Concurrent or prior use (within 30 days) of buspirone, warfarin, haloperidol, and drugs to treat seizures (e.g., phenytoin and carbamazepine)
• Women breast feeding or known to be pregnant
• Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
• Failure to give informed consent