search
Back to results

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
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 19, 2007
Last Updated
April 12, 2017
Sponsor
The Cleveland Clinic
search

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:
PubMed Identifier
9468233
Citation
Mertz H, Fass R, Kodner A, Yan-Go F, Fullerton S, Mayer EA. Effect of amitriptyline on symptoms, sleep, and visceral perception in patients with functional dyspepsia. Am J Gastroenterol. 1998 Feb;93(2):160-5. doi: 10.1111/j.1572-0241.1998.00160.x.
Results Reference
background
PubMed Identifier
8726297
Citation
Tanum L, Malt UF. A new pharmacologic treatment of functional gastrointestinal disorder. A double-blind placebo-controlled study with mianserin. Scand J Gastroenterol. 1996 Apr;31(4):318-25. doi: 10.3109/00365529609006404.
Results Reference
background
PubMed Identifier
10027672
Citation
Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9.
Results Reference
background
PubMed Identifier
16441473
Citation
Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, Barkun AN, Thomson AB, Mann V, Escobedo S, Chakraborty B, Nevin K. Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials. Aliment Pharmacol Ther. 2006 Feb 15;23(4):521-9. doi: 10.1111/j.1365-2036.2006.02774.x.
Results Reference
background
PubMed Identifier
16322947
Citation
Hojo M, Miwa H, Yokoyama T, Ohkusa T, Nagahara A, Kawabe M, Asaoka D, Izumi Y, Sato N. Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol. 2005 Nov;40(11):1036-42. doi: 10.1007/s00535-005-1687-8.
Results Reference
background
PubMed Identifier
8677926
Citation
Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyren O, Bradley LA, Verlinden M, Tytgat GN. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol. 1996 Apr;91(4):660-73.
Results Reference
background
PubMed Identifier
16181387
Citation
Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005 Oct;100(10):2324-37. doi: 10.1111/j.1572-0241.2005.00225.x.
Results Reference
background
PubMed Identifier
11059442
Citation
Jackson JL, O'Malley PG, Tomkins G, Balden E, Santoro J, Kroenke K. Treatment of functional gastrointestinal disorders with antidepressant medications: a meta-analysis. Am J Med. 2000 Jan;108(1):65-72. doi: 10.1016/s0002-9343(99)00299-5.
Results Reference
background
PubMed Identifier
11276271
Citation
Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001 Apr;32(4):286-93. doi: 10.1097/00004836-200104000-00004.
Results Reference
background
PubMed Identifier
11467624
Citation
Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am J Gastroenterol. 2001 Jul;96(7):1998-2004. doi: 10.1111/j.1572-0241.2001.03932.x.
Results Reference
background
PubMed Identifier
16678567
Citation
Design of Treatment Trials Committee; Irvine EJ, Whitehead WE, Chey WD, Matsueda K, Shaw M, Talley NJ, Veldhuyzen van Zanten SJ. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006 Apr;130(5):1538-51. doi: 10.1053/j.gastro.2005.11.058.
Results Reference
background
PubMed Identifier
10457048
Citation
Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR. Design of treatment trials for functional gastrointestinal disorders. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II69-77. doi: 10.1136/gut.45.2008.ii69.
Results Reference
background
PubMed Identifier
15521002
Citation
Moayyedi P, Delaney BC, Vakil N, Forman D, Talley NJ. The efficacy of proton pump inhibitors in nonulcer dyspepsia: a systematic review and economic analysis. Gastroenterology. 2004 Nov;127(5):1329-37. doi: 10.1053/j.gastro.2004.08.026.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs