Can an antidepressant soothe stomach pain?
NCT ID NCT00547703
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial tests whether nortriptyline, an antidepressant, can reduce abdominal pain and improve quality of life in people with nonulcer dyspepsia—a condition causing stomach discomfort without an ulcer. Participants take either nortriptyline or a placebo capsule nightly for 8 weeks. The study measures relief of pain and changes in quality of life to see if this drug offers a new way to manage the condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nortriptyline (an antidepressant) taken as a 25mg capsule nightly for 8 weeks, compared to a placebo.
- What this could lead to
- If effective, nortriptyline could offer a new treatment option for people with nonulcer dyspepsia, improving their pain and daily quality of life.
- What could go wrong
- This is a very small early trial, so results may not apply widely. Nortriptyline can cause side effects like drowsiness, dry mouth, or dizziness, and may not outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5 people
The number who actually took part.
- Start date
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Feb 2008
- Finished
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Jun 2010
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and Women * Ages 18-65 * Meet Rome III criteria for functional dyspepsia * Endoscopy within 1 year Exclusion Criteria: * Allergic reaction or history of adverse events with Nortriptyline or tricyclic antidepressants * Organic cause found on physical examination * Organic cause found on lab work: Complete Blood Count, Comprehensive Metabolic Panel, Thyroid stimulating hormone, Tissue transglutaminase Immunoglobulin A * Predominantly Gastroesophageal reflux symptoms * Current Helicobacter pylori infection * History of Peptic ulcer disease * Non steroidal antiinflammatory use use \> 2x/wk * Pregnant or planning pregnancy * History of major depression * Abdominal surgery in the last year
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic Florida
Weston, Florida, 33331, United States