Functional DyspepsiaPhase 3NCT01052896
Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
A Phase 3 study testing Gabapentin in people with Functional Dyspepsia, run by 59th Medical Wing at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to 28 Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Antonio Military Medical Center - North
San Antonio, Texas, 78236
San Antonio Military Medical Center - South
San Antonio, Texas, 78236
About this study
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.
Read the 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.
- Conditions
- Functional Dyspepsia
- Being tested
- Gabapentin, Placebo
- Keywords
- Dyspepsia, Functional
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
300mg po TID
PlaceboDrug
Look-alike of gabapentin 300mg given po tid
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms. Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Half of the 100 patients will be placed on placebo look-alike of the gabapentin. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the adequacy of symptom control during the last week of the study.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startMar 2010 (estimated)
- Primary completionMar 2011 (estimated)
- Study completion28 Aug 2012
Why it stopped: Unable to recruit subjects - unworkable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jeffrey W Molloy, MD, Principal investigator, Gastroenterology Division - SAMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052896
- Sponsor's protocol ID
- FWH20090188H
- Other IDs
- WS499026
- Status last verified
- Sep 2020
- First submitted
- 20 Jan 2010
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
- ClinicalTrials.gov ID
- NCT01052896
- Acronym / sponsor ID
- FWH20090188H
- Conditions
- Functional Dyspepsia
- Keywords
- Dyspepsia, Functional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit subjects - unworkable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- Pfizer
- Study start
- Mar 2010 (estimated)
- Primary completion
- Mar 2011 (estimated)
- Study completion
- 28 Aug 2012 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinHalf of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms. |
| Placebo | Placebo comparator | Drug: PlaceboHalf of the 100 patients will be placed on placebo look-alike of the gabapentin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: Neurontin300mg po TID | Drug | Gabapentin |
| PlaceboLook-alike of gabapentin 300mg given po tid | Drug | Placebo |
Primary outcome
The primary outcome will be the adequacy of symptom control during the last week of the study.
Time frame: 2 months
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey W Molloy, MD principal investigator
Gastroenterology Division - SAMMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Functional Dyspepsia, run by 59th Medical Wing at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the adequacy of symptom control during the last week of the study. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.