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
Recruitment status was Not yet recruiting
Sponsor:
Wilford Hall Medical Center
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
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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 May 16, 2013