Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01052896
Study type	Interventional
Source	59th Medical Wing
Contact
Status	Withdrawn
Phase	Phase 3
Start date	March 2010
Completion date	August 28, 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04464369` - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial	Phase 4
Completed	`NCT01671670` - Acupuncture for Patients With Function Dyspepsia	Phase 2/Phase 3
Completed	`NCT00987805` - Efficacy of Banhasasim-tang on Functional Dyspepsia	Phase 4
Completed	`NCT00761358` - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia	Phase 3
Completed	`NCT00693407` - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation	N/A
Recruiting	`NCT01240096` - Mirtazapine Versus Placebo in Functional Dyspepsia	Phase 4
Recruiting	`NCT04540549` - Effects of Exercise on Functional Dyspepsia Based on Rome IV	N/A
Recruiting	`NCT03652571` - Nortriptyline for the Treatment of Functional Dyspepsia	Phase 3
Recruiting	`NCT06068114` - Gastric Pathophysiology in Diabetes
Recruiting	`NCT03825692` - International Clinical Study of Zhizhu Kuanzhong Capsule	Phase 4
Not yet recruiting	`NCT04548011` - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia	N/A
Terminated	`NCT02567578` - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia	Phase 2
Completed	`NCT03007433` - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging	N/A
Active, not recruiting	`NCT00990405` - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia	Phase 4
Completed	`NCT00404534` - Helicobacter Eradication Relief of Dyspeptic Symptoms	Phase 3
Completed	`NCT03043625` - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia	N/A
Completed	`NCT03225248` - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia	Phase 3
Recruiting	`NCT05587127` - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia	N/A
Recruiting	`NCT01021475` - Does Visceral Manipulation Works in Treating Functional Dyspepsia?	Phase 1