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

January 20, 2010
January 20, 2010
March 2010
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Gabapentin
    300mg po TID
    Other Name: Neurontin
  • Drug: Placebo
    Look-alike of gabapentin 300mg given po tid
  • Experimental: Gabapentin
    Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Half of the 100 patients will be placed on placebo look-alike of the gabapentin.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
May 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
United States
 
NCT01052896
FWH20090188H, WS499026
No
Jeffrey W. Molloy, MD, FACP, San Antonio Military Medical Center (SAMMC) Gastroenterology Division
Wilford Hall Medical Center
Pfizer
Principal Investigator: Jeffrey W Molloy, MD Gastroenterology Division - SAMMC
Wilford Hall Medical Center
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP