Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition



Status:Completed
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:March 2010
End Date:May 2011
Contact:Jeffrey W Molloy, MD
Email:jeffrey.molloy@lackland.af.mil
Phone:210-292-6408

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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.

In this pilot study we hypothesize that the patients on gabapentin will have an increase in
the adequacy of dyspepsia symptom control at two months as well as improvement in dyspepsia
symptom index scores which are a surrogate of quality of life measures, when compared to
placebo.

While functional dyspepsia is divided into four subtypes most studies have grouped all four
as 'functional dyspepsia' and treated them as one. Proton pump inhibition may benefit those
with epigastric pain or burning but typically not those with post-prandial fullness or early
satiety. (Tack et al). Those patients with symptoms refractory to proton pump inhibition
might benefit from a medication that modifies visceral hypersensitivity such as gabapentin.
It is possible that by modifying their pain syndrome we can decrease the need for follow-up
appointments and improve patient quality of life.

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.
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