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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
History of Changes

October 19, 2007
June 7, 2012
February 2008
April 2010   (final data collection date for primary outcome measure)
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.
To assess if Nortriptyline improves abdominal pain/discomfort in patients with nonulcer dyspepsia [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00547703 on ClinicalTrials.gov Archive Site
  • 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.
  • To assess if Nortriptyline improves quality of life in patients with nonulcer dyspepsia [ Time Frame: 8 weeks ]
  • To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Ulcer Dyspepsia
  • Drug: Nortriptyline
    Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
    Other Name: Pamelor
  • Drug: Placebo
    An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
    Other Name: Sugar pill
  • Active Comparator: Nortriptyline
    Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
    Intervention: Drug: Nortriptyline
  • Placebo Comparator: Sugar pill
    Patients in this group will receive an identical placebo capsule at night for 8 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
June 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547703
IRB 8918
No
Fernando Castro, Cleveland Clinic Florida
Cleveland Clinic Florida
Not Provided
Principal Investigator: Fernando Castro, MD Cleveland Clinic Florida
Cleveland Clinic Florida
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP