Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

NCT01052896

Last updated date
Study Location
San Antonio Military Medical Center - North
San Antonio, Texas, 78236, United States
Contact
210-292-6408

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Functional Dyspepsia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Functional DyspepsiaGabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
NCT01052896
  1. San Antonio, Texas
  2. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
Official Title  ICMJE Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE
  • Drug: Gabapentin
    300mg po TID
    Other Name: Neurontin
  • Drug: Placebo
    Look-alike of gabapentin 300mg given po tid
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 20, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01052896
Other Study ID Numbers  ICMJE FWH20090188H
WS499026 ( Other Grant/Funding Number: Pfizer Pharmaceuticals )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey W. Molloy, MD, FACP, San Antonio Military Medical Center (SAMMC) Gastroenterology Division
Study Sponsor  ICMJE 59th Medical Wing
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jeffrey W Molloy, MDGastroenterology Division - SAMMC
PRS Account 59th Medical Wing
Verification Date January 2010

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