Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Phase

Condition

Bowel Dysfunction

Gastroparesis

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01052896

FWH20090188H

WS499026

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients to be included in this study are adults (age >18 years) with definedfunctional dyspepsia per the ROME III criteria with a negative EGD who are on protonpump inhibitor therapy yet still have a sense of inadequate symptom control.

Exclusion

Exclusion Criteria:

Patients excluded will be women of childbearing age who refuse to have a baselinepregnancy test and/or who refuse to prevent pregnancy during the trial period.Exclusion criteria will also include anyone with a history of adverse effect orallergy to gabapentin. Finally, any patient undergoing hemodialysis or with a historyof creatinine chronically greater than 1.5 will be excluded.

Study Design

March 01, 2010

August 28, 2012

Study Description

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.

Connect with a study center

San Antonio Military Medical Center - North
San Antonio, Texas 78236
United States
Site Not Available
San Antonio Military Medical Center - South
San Antonio, Texas 78236
United States
Site Not Available

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