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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Recruitment Status : Withdrawn (Unable to recruit subjects - unworkable)
First Posted : January 21, 2010
Last Update Posted : October 1, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Gabapentin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Estimated Study Start Date : March 2010
Estimated Primary Completion Date : March 2011
Actual Study Completion Date : August 28, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01052896

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United States, Texas
San Antonio Military Medical Center - North
San Antonio, Texas, United States, 78236
San Antonio Military Medical Center - South
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
59th Medical Wing
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Principal Investigator: Jeffrey W Molloy, MD Gastroenterology Division - SAMMC
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Responsible Party: 59th Medical Wing Identifier: NCT01052896    
Other Study ID Numbers: FWH20090188H
WS499026 ( Other Grant/Funding Number: Pfizer Pharmaceuticals )
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Keywords provided by 59th Medical Wing:
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents