Buspirone for Early Satiety and Symptoms of Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Buspirone; Placebo
Intervention description: Buspirone tablet; "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Intervention MeSH terms: Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Participants, all clinic staff and the investigators will be masked as to whether the participant is receiving buspirone or the placebo.
The 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.
The 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.
The 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.
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: gastroparesis; early satiety; stomach; buspirone; 5-HT 1a receptor agonist

Summary:

      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.
    

Eligibility criteria:

        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