Clinical trial NCT01052896: Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
Official title: Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Functional Dyspepsia
Keywords: Dyspepsia
Functional
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: Pfizer
First posted: 2010-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome will be the adequacy of symptom control during the last week of the study.
timeFrame: 2 months
Secondary outcomes:
measure: 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.
timeFrame: 2 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center - North
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center - South
state: Texas
Study officials:
affiliation: Gastroenterology Division - SAMMC
name: Jeffrey W Molloy, MD
role: PRINCIPAL_INVESTIGATOR
References: