Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
NCT01052896
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | August 28, 2012 | |||
Estimated Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | 59th Medical Wing | |||
Study Sponsor ICMJE | 59th Medical Wing | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | 59th Medical Wing | |||
Verification Date | September 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |