Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial (BESST)

10- GpCRC3-BESST

This study evaluates whether the study medication, buspirone, an antianxiety drug, improves the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately severe symptoms of fullness and/or inability to eat a full meal. Half the patients will receive buspirone and half the patients will receive a placebo.

2019-08-27

2022-04-15

2022-04-30

Completed

Early phase I

96

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'BESST is a multi-center, randomized, placebo-controlled, double-masked, parallel treatment groups phase 2 trial with half the participants receiving the study drug, buspirone, and half receiving the placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants, all clinic staff and the investigators will be masked as to whether the participant is receiving buspirone or the placebo.\n\nThe study drug will be over encapsulated in a size 0 gelatin capsule with partial filler to be identical to the placebo capsule, which contains only filler.\n\nThe random treatment assignment will consist of a numbered study drug bottle; each bottle number will be unique and each participant will be assigned a specific bottle number, which is labelled: "Buspirone or placebo 10 mg." with directions.\n\nThe randomization scheme will assign participants in randomly permuted blocks of assignments stratified by clinical center. The randomization plan will be prepared and administered centrally via a secure web application by the Scientific Data Research Center.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}

2023-06-15