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.
|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|
- 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.
- 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.
|Study Start Date:||February 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Nortriptyline
Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
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.
An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
Other Name: Sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547703
|United States, Florida|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|Principal Investigator:||Fernando Castro, MD||Cleveland Clinic Florida|