Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01052896
Recruitment Status : Unknown
Verified January 2010 by Wilford Hall Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 21, 2010
Last Update Posted : January 21, 2010
Information provided by:
Wilford Hall Medical Center

January 20, 2010
January 21, 2010
January 21, 2010
March 2010
March 2011   (Final data collection date for primary outcome measure)
The primary outcome will be the adequacy of symptom control during the last week of the study. [ Time Frame: 2 months ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Gabapentin
    300mg po TID
    Other Name: Neurontin
  • Drug: Placebo
    Look-alike of gabapentin 300mg given po tid
  • Experimental: Gabapentin
    Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Half of the 100 patients will be placed on placebo look-alike of the gabapentin.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
WS499026 ( Other Grant/Funding Number: Pfizer Pharmaceuticals )
Not Provided
Not Provided
Jeffrey W. Molloy, MD, FACP, San Antonio Military Medical Center (SAMMC) Gastroenterology Division
Wilford Hall Medical Center
Principal Investigator: Jeffrey W Molloy, MD Gastroenterology Division - SAMMC
Wilford Hall Medical Center
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP