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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Non Ulcer Dyspepsia

Treatments: Drug: Placebo; Drug: Nortriptyline

Study type: Interventional

Funder types: Other

Identifiers

NCT00547703

IRB 8918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Nortriptyline

Active Comparator group

Description:

Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.

Treatment:

Drug: Nortriptyline

Sugar pill

Placebo Comparator group

Description:

Patients in this group will receive an identical placebo capsule at night for 8 weeks.

Treatment:

Drug: Placebo