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

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Nortriptyline	Nortriptyline	Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.	8 weeks	Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.

Secondary Outcome Measures

Name	Time	Method
QOLRAD Questionaire for Patients With Upper Abdominal Symptoms	8 weeks	Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia
Side Effects	8 weeks	To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.