Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Wilford Hall Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT01052896
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Functional Dyspepsia
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • The primary outcome will be the adequacy of symptom control during the last week of the study. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052896

Contacts
Contact: Jeffrey W Molloy, MD 210-292-6408 jeffrey.molloy@lackland.af.mil
Contact: Stephen Harrison, MD 210-916-3647 stephen.harrison@amedd.army.mil

Locations
United States, Texas
San Antonio Military Medical Center - North Not yet recruiting
San Antonio, Texas, United States, 78236
Contact: Jeffrey W Molloy, MD    210-292-6408    jeffrey.molloy@lackland.af.mil   
Sub-Investigator: Stephen Harrison, MD         
Sub-Investigator: Hays Arnold, MD         
Principal Investigator: Jeffrey W Molloy, MD         
San Antonio Military Medical Center - South Not yet recruiting
San Antonio, Texas, United States, 78236
Contact: Jeffrey W Molloy, MD    210-916-3647    jeffrey.molloy@lackland.af.mil   
Principal Investigator: Jeffrey W Molloy, MD         
Sub-Investigator: Nicole Palekar, MD         
Sponsors and Collaborators
Wilford Hall Medical Center
Pfizer
Investigators
Principal Investigator: Jeffrey W Molloy, MD Gastroenterology Division - SAMMC
  More Information

No publications provided

Responsible Party: Jeffrey W. Molloy, MD, FACP, San Antonio Military Medical Center (SAMMC) Gastroenterology Division
ClinicalTrials.gov Identifier: NCT01052896     History of Changes
Other Study ID Numbers: FWH20090188H, WS499026
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
Dyspepsia
Functional

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 16, 2014