Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

Last updated: April 12, 2017
Sponsor: The Cleveland Clinic
Overall Status: Terminated

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Colic

Ulcerative Colitis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00547703
IRB 8918
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and Women

  • Ages 18-65

  • Meet Rome III criteria for functional dyspepsia

  • Endoscopy within 1 year

Exclusion

Exclusion Criteria:

  • Allergic reaction or history of adverse events with Nortriptyline or tricyclicantidepressants

  • 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

Study Design

Total Participants: 5
Study Start date:
February 01, 2008
Estimated Completion Date:
June 30, 2010

Study Description

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.

Connect with a study center

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

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