Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Gabapentin

Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

300mg po TID

Placebo

Half of the 100 patients will be placed on placebo look-alike of the gabapentin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Look-alike of gabapentin 300mg given po tid

Interventions

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Gabapentin

300mg po TID

Intervention Type DRUG

Placebo

Look-alike of gabapentin 300mg given po tid

Intervention Type DRUG

Other Intervention Names

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Neurontin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No