Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Official Title: “Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition”

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • 300mg po TID
• Drug: Placebo
  • Look-alike of gabapentin 300mg given po tid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin
  • Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
• Placebo Comparator: Placebo
  • Half of the 100 patients will be placed on placebo look-alike of the gabapentin.

Primary Measures

• The primary outcome will be the adequacy of symptom control during the last week of the study.
  • Time Frame: 2 months
    Safety Issue?: Yes

Secondary Measures

• 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.
  • Time Frame: 2 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Wilford Hall Medical Center U.S. Fed

Overall Clinical Trial Officials and Contacts

Jeffrey W Molloy, MD Principal Investigator Gastroenterology Division - SAMMC  

Overall Contact: Jeffrey W Molloy, MD 210-292-6408 jeffrey.molloy@lackland.af.mil

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01052896

Study ID Number: FWH20090188H

ClinicalTrials.gov Identifier: NCT01052896

Health Authority: United States: Federal Government