Functional Dyspepsia | Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
Functional Dyspepsia research study
What is the primary objective of this study?
The purpose of this study is to evaluate the effectiveness of gabapentin on symptom control in patients with defined functional dyspepsia refractory to conventional proton pump inhibitor therapy and to compare these effects to that of placebo.
Who is eligible to participate?
Inclusion Criteria: - Patients to be included in this study are adults (age >18 years) with defined functional dyspepsia per the ROME III criteria with a negative EGD who are on proton pump inhibitor therapy yet still have a sense of inadequate symptom control. Exclusion Criteria: - Patients excluded will be women of childbearing age who refuse to have a baseline pregnancy test and/or who refuse to prevent pregnancy during the trial period. Exclusion criteria will also include anyone with a history of adverse effect or allergy to gabapentin. Finally, any patient undergoing hemodialysis or with a history of creatinine chronically greater than 1.5 will be excluded.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Gabapentin300mg po TID
Drug:PlaceboLook-alike of gabapentin 300mg given po tid
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
GabapentinHalf of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
PlaceboHalf of the 100 patients will be placed on placebo look-alike of the gabapentin.
Start Date: March 2010
Completed Date: May 2011
Phase: Phase 3
Primary Outcome: The primary outcome will be the adequacy of symptom control during the last week of the study.
Secondary Outcome: Secondary outcomes equate dyspepsia symptoms with quality of life. The Nepean Dyspepsia Index scores patients on five categories while the Global Overall Symptom Scale measures the severity of dyspepsia on a 1-7 scale.
Study sponsors, principal investigator, and references
Principal Investigator: Jeffrey W Molloy, MD
Lead Sponsor: Wilford Hall Medical Center