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

The Cleveland Clinic5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non Ulcer Dyspepsia

Interventions

NortriptylineDRUG

Nortriptyline 25mg capsule, orally administered, every night for 8 weeks

PlaceboDRUG

An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Florida

Weston, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

Quality Of Life in Reflux and Dyspepsia (QOLRAD)

Patients were administered the validated QOLRAD (Quality of Life in Reflux and Dyspepsia) questionnaire to assess if nortriptyline improves quality of life in patients with non-ulcer dyspepsia. The total score range is 25 to 175. Higher scores indicate better quality of life.

Time frame: 8 weeks

Number of Participants With Side Effects

To assess the number of patients who experienced side effects. Patients were asked about side effects on each office visit and ask to call for significant side effects.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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