Expired Study
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Weston, Florida 33331


Purpose:

The purpose of this study is to determine if use of Nortriptyline will improve symptoms and quality of life in patients who have nonulcer dyspepsia.


Study summary:

Nonulcer dyspepsia is a common complaint in clinical practice and its management should be based on the best evidence. Many clinical trials of nonulcer dyspepsia suffer from important weaknesses in trial design. This makes it difficult to determine whether truly efficacious therapies exist for this disorder. Once a diagnosis of nonulcer dyspepsia is confirmed by normal endoscopy, a trial of therapy is commonly prescribed. However, the benefits of all therapies in this condition have been questioned. Small studies have suggested benefit in use of antidepressants such as Nortriptyline and even though the data is insufficient, antidepressants such as Nortriptyline are widely used in clinical practice largely due to lack of proven, reliable therapies for nonulcer dyspepsia. Our hypothesis is that Nortriptyline will improve symptoms of nonulcer dyspepsia and improve quality of life.


Criteria:

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: CBC, CMP, TSH, Tissue transglutaminase IgA - Predominantly GERD symptoms - Current Helicobacter pylori infection - History of PUD - NSAID use > 2x/wk - Pregnant or planning pregnancy - History of major depression - Abdominal surgery in the last year


NCT ID:

NCT00547703


Primary Contact:

Principal Investigator
Fernando Castro, MD
Cleveland Clinic Florida


Backup Contact:

N/A


Location Contact:

Weston, Florida 33331
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 21, 2017

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