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

Information source: Cleveland Clinic Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Ulcer Dyspepsia

Intervention: Nortriptyline (Drug); Placebo (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Cleveland Clinic Florida

Official(s) and/or principal investigator(s):
Fernando Castro, MD, Principal Investigator, Affiliation: Cleveland Clinic Florida


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.

Clinical Details

Official title: Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With 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

Primary outcome: Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.

Secondary outcome:

QOLRAD Questionaire for Patients With Upper Abdominal Symptoms

Side Effects

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Cleveland Clinic Florida, Weston, Florida 33331, United States
Additional Information

Related publications:

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.

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.

Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Paré 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.

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.

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. Review.

Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyrén 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.

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.

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.

Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001 Apr;32(4):286-93. Review.

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.

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. Review.

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:II69-77.

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. Review.

Starting date: February 2008
Last updated: June 7, 2012

Page last updated: August 23, 2015

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