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| ID | Type | Description | Link |
|---|---|---|---|
| WS499026 | Other Grant/Funding Number | Pfizer Pharmaceuticals |
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Unable to recruit subjects - unworkable
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms. |
|
| Placebo | Placebo Comparator | Half of the 100 patients will be placed on placebo look-alike of the gabapentin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 300mg po TID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the adequacy of symptom control during the last week of the study. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey W Molloy, MD | Gastroenterology Division - SAMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center - North | San Antonio | Texas | 78236 | United States | ||
| San Antonio Military Medical Center - South |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo |
| Drug |
Look-alike of gabapentin 300mg given po tid |
|
| San Antonio |
| Texas |
| 78236 |
| United States |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |