Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Primary Purpose
Non Ulcer Dyspepsia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nortriptyline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Ulcer Dyspepsia focused on measuring Nonulcer dyspepsia, Functional dyspepsia, Antidepressant use in dyspepsia, Nortriptyline, Tricyclic antidepressants
Eligibility 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
Sites / Locations
- Cleveland Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nortriptyline
Sugar pill
Arm Description
Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00547703
Brief Title
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Official Title
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants - only 5 since the study started
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Ulcer Dyspepsia
Keywords
Nonulcer dyspepsia, Functional dyspepsia, Antidepressant use in dyspepsia, Nortriptyline, Tricyclic antidepressants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nortriptyline
Arm Type
Active Comparator
Arm Description
Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Nortriptyline
Other Intervention Name(s)
Pamelor
Intervention Description
Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
Primary Outcome Measure Information:
Title
Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.
Description
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
Secondary Outcome Measure Information:
Title
QOLRAD Questionaire for Patients With Upper Abdominal Symptoms
Description
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
Title
Side Effects
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Castro, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
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