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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non Ulcer Dyspepsia

Intervention / Treatment
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* Drug: Nortriptyline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nortriptyline<br>Patients in this group will receive Nortriptyline 25mg at night for 8 weeks. | Drug: Nortriptyline<br>* Nortriptyline 25mg capsule, orally administered, every night for 8 weeks<br>* Other names: Pamelor;|
| Placebo Comparator: Sugar pill<br>Patients in this group will receive an identical placebo capsule at night for 8 weeks. | Drug: Placebo<br>* An identical placebo capsule containing lactose, administered orally, every night for 8 weeks<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOLRAD Questionaire for Patients With Upper Abdominal Symptoms | Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia | 8 weeks | 
| Side Effects | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonulcer dyspepsia, Functional dyspepsia, Antidepressant use in dyspepsia, Nortriptyline, Tricyclic antidepressants