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

July 31, 2026 updated by: Fernando Castro, The Cleveland Clinic
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

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.
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Fernando Castro, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimated)

October 23, 2007

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 8918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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