Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

NCT01052896 | Withdrawn Phase 3

• 2 other identifiers: FWH20090188HWS499026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Dyspepsia

Keywords

Dyspepsia; Functional

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the adequacy of symptom control during the last week of the study.

  2 months

Secondary Outcomes (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.

  2 months

Study Arms (2)

Gabapentin

EXPERIMENTAL

Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Half of the 100 patients will be placed on placebo look-alike of the gabapentin.

Drug: Placebo

Interventions

Gabapentin DRUG

300mg po TID

Also known as: Neurontin

Gabapentin

Placebo DRUG

Look-alike of gabapentin 300mg given po tid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• 59th Medical Wing: lead
• Pfizer: collaborator

Study Sites (2)

San Antonio Military Medical Center - North

San Antonio, Texas, 78236, United States

Location

San Antonio Military Medical Center - South

San Antonio, Texas, 78236, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey W Molloy, MD

  Gastroenterology Division - SAMMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: August 28, 2012
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

US (2)