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

This study has been terminated.
(Not enough participants - only 5 since the study started)
Sponsor:
Information provided by (Responsible Party):
Fernando Castro, Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00547703
First received: October 19, 2007
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention
Non Ulcer Dyspepsia
Drug: Nortriptyline
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • QOLRAD Questionaire for Patients With Upper Abdominal Symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia

  • Side Effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 5
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547703

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
Principal Investigator: Fernando Castro, MD Cleveland Clinic Florida
  More Information

Publications:

Responsible Party: Fernando Castro, Principal investigator, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00547703     History of Changes
Other Study ID Numbers: IRB 8918
Study First Received: October 19, 2007
Results First Received: February 20, 2012
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
Nonulcer dyspepsia
Functional dyspepsia
Antidepressant use in dyspepsia
Nortriptyline
Tricyclic antidepressants

Additional relevant MeSH terms:
Abdominal Pain
Dyspepsia
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Nortriptyline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014