This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Wilford Hall Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Wilford Hall Medical Center Identifier:
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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.

Condition Intervention Phase
Functional Dyspepsia Drug: Gabapentin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Resource links provided by NLM:

Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • The primary outcome will be the adequacy of symptom control during the last week of the study. [ Time Frame: 2 months ]

Secondary Outcome 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 ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin
Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
Drug: Gabapentin
300mg po TID
Other Name: Neurontin
Placebo Comparator: Placebo
Half of the 100 patients will be placed on placebo look-alike of the gabapentin.
Drug: Placebo
Look-alike of gabapentin 300mg given po tid

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01052896

Contact: Jeffrey W Molloy, MD 210-292-6408
Contact: Stephen Harrison, MD 210-916-3647

United States, Texas
San Antonio Military Medical Center - North Not yet recruiting
San Antonio, Texas, United States, 78236
Contact: Jeffrey W Molloy, MD    210-292-6408   
Sub-Investigator: Stephen Harrison, MD         
Sub-Investigator: Hays Arnold, MD         
Principal Investigator: Jeffrey W Molloy, MD         
San Antonio Military Medical Center - South Not yet recruiting
San Antonio, Texas, United States, 78236
Contact: Jeffrey W Molloy, MD    210-916-3647   
Principal Investigator: Jeffrey W Molloy, MD         
Sub-Investigator: Nicole Palekar, MD         
Sponsors and Collaborators
Wilford Hall Medical Center
Principal Investigator: Jeffrey W Molloy, MD Gastroenterology Division - SAMMC
  More Information

Responsible Party: Jeffrey W. Molloy, MD, FACP, San Antonio Military Medical Center (SAMMC) Gastroenterology Division Identifier: NCT01052896     History of Changes
Other Study ID Numbers: FWH20090188H
WS499026 ( Other Grant/Funding Number: Pfizer Pharmaceuticals )
Study First Received: January 20, 2010
Last Updated: January 20, 2010

Keywords provided by Wilford Hall Medical Center:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents processed this record on September 21, 2017