Non Ulcer Dyspepsia
Conditions
Keywords
Nonulcer dyspepsia, Functional dyspepsia, Antidepressant use in dyspepsia, Nortriptyline, Tricyclic antidepressants
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.
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.
Interventions
DRUGNortriptyline
Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
DRUGPlacebo
An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality Of Life in Reflux and Dyspepsia (QOLRAD) | 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. |
| Number of Participants With Side Effects | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFernando Castro, MD
Cleveland Clinic Florida
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nortriptyline Patients in this group will receive Nortriptyline 25mg at night for 8 weeks. | 4 |
| Placebo Patients in this group will receive an identical placebo capsule at night for 8 weeks. | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | Placebo | Nortriptyline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 0 | 42 years STANDARD_DEVIATION 4 | 42 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 1 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 2 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.
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.
Time frame: 8 weeks
Population: All patients who completed the 8 weeks of the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nortriptyline | Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 2 participants |
| Placebo | Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 1 participants |
Secondary
QOLRAD Questionaire for Patients With Upper Abdominal Symptoms
Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia
Time frame: 8 weeks
Secondary
Side Effects
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.
Time frame: 8 weeks