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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547703
Recruitment Status : Terminated (Not enough participants - only 5 since the study started)
First Posted : October 23, 2007
Results First Posted : July 10, 2012
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):
Fernando Castro, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Ulcer Dyspepsia Drug: Nortriptyline Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Study Start Date : February 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Sugar pill

Primary Outcome Measures :
  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 Outcome Measures :
  1. QOLRAD Questionaire for Patients With Upper Abdominal Symptoms [ Time Frame: 8 weeks ]
    Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia

  2. Side Effects [ Time Frame: 8 weeks ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547703

United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Fernando Castro, MD Cleveland Clinic Florida


Responsible Party: Fernando Castro, Principal investigator, The Cleveland Clinic Identifier: NCT00547703     History of Changes
Other Study ID Numbers: IRB 8918
First Posted: October 23, 2007    Key Record Dates
Results First Posted: July 10, 2012
Last Update Posted: May 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fernando Castro, The Cleveland Clinic:
Nonulcer dyspepsia
Functional dyspepsia
Antidepressant use in dyspepsia
Tricyclic antidepressants

Additional relevant MeSH terms:
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs