Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Phase 3

Withdrawn

• Conditions: Functional Dyspepsia
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT01052896
• Lead Sponsor: 59th Medical Wing

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-03
• Primary Completion: 2011-03
• Study Completion: 2012-08-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Half of the 100 patients will be placed on placebo look-alike of the gabapentin.
Gabapentin	Gabapentin	Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the adequacy of symptom control during the last week of the study.	2 months

Secondary Outcome Measures

Name	Time	Method
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.	2 months

Trial Locations

Locations (2)

San Antonio Military Medical Center - North; 🇺🇸 San Antonio, Texas, United States

San Antonio Military Medical Center - South; 🇺🇸 San Antonio, Texas, United States