Dr. Brian E. Lacy is a board certified gastroenterologist who focuses his research and clinical interests on disorders of gastrointestinal motility. Dr. Lacy's areas of expertise include gastroesophageal reflux disease, dysphagia, achalasia, dyspepsia, gastroparesis, irritable bowel syndrome, constipation, intestinal pseudo-obstruction and visceral pain. Dr. Lacy is the author of over 165 peer-reviewed articles on gastrointestinal motility disorders and functional bowel disorders, has written and/or edited 6 books on gastrointestinal motility disorders and functional bowel disorders, and has written multiple text book chapters. Dr. Lacy is the current co-Editor in Chief of the American Journal of Gastroenterology. He is the former Editor in Chief of Clinical and Translational Gastroenterology. Dr. Lacy was the co-Chairman for the Rome IV Committee on Functional Bowel Disorders.

 Antidepressant Therapy for Functional Dyspepsia

We propose to investigate whether antidepressant medications are efficacious in functional dyspepsia. The prescription of antidepressants to treat functional dyspepsia is based on three propositions. First, antidepressants could reduce the severity of co-morbid psychological symptoms, especially anxiety and depression. Second, antidepressants have central analgesic actions. Thirdly, antidepressants have been shown to have local pharmacological actions on the gut, and may specifically alter gastric emptying and fundic relaxation based on preliminary data, but the relevance of such pertubations to treatment outcome is not established.

Estimated Enrollment: 400
Study Start Date: October 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

 Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.

Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

 Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

 Study of Promethazine for Treatment of Diabetic Gastroparesis

Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.

Estimated Enrollment: 24
Study Start Date: July 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)