NCT01052896

Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: 59th Medical Wing · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Gabapentin	300mg po TID
DRUG	Placebo	Look-alike of gabapentin 300mg given po tid

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2012-08-28
• First posted: 2010-01-21
• Last updated: 2020-10-01

Locations

2 sites across 1 country: United States