Clinical trial NCT00547703: Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Official title: Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Ulcer Dyspepsia
Keywords: Nonulcer dyspepsia
Functional dyspepsia
Antidepressant use in dyspepsia
Nortriptyline
Tricyclic antidepressants
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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: 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

Primary outcomes:
measure: Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.
timeFrame: 8 weeks
Secondary outcomes:
measure: QOLRAD Questionaire for Patients With Upper Abdominal Symptoms
timeFrame: 8 weeks
measure: Side Effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Fernando Castro, MD
role: PRINCIPAL_INVESTIGATOR
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