Skip to main content
OpenTrials
Terminated

NCT Number: NCT00547703

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

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.

Why the study stopped: Not enough participants - only 5 since the study started
Terminated

Looking for future studies?

Notify Me

Key information

Conditions

Non Ulcer Dyspepsia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nortriptyline

Drug

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

Other names: Pamelor

Placebo

Drug

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

Other names: Sugar pill

Primary outcomes

  1. Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.

    Time frame: 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 outcomes

  1. Quality Of Life in Reflux and Dyspepsia (QOLRAD)

    Time frame: 8 weeks

    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.

  2. Number of Participants With Side Effects

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2007
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.