Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Functional Dyspepsia Clinical Trial

Official title:

Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01052896
• Other study ID #: FWH20090188H
• Secondary ID: WS499026
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: August 28, 2012

Study information

• Verified date: September 2020
• Source: 59th Medical Wing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 28, 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center - North	San Antonio	Texas
United States	San Antonio Military Medical Center - South	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
59th Medical Wing	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the adequacy of symptom control during the last week of the study.		2 months
Secondary	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.		2 months