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

Condition(s) targeted: Nonulcer Dyspepsia

Intervention: Nortriptyline (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Cleveland Clinic Florida

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

Overall contact:
Fernando Castro, MD, Phone: 954-659-5000, Email: castrof@ccf.org

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To assess if Nortriptyline improves abdominal pain/discomfort in patients with nonulcer dyspepsia

Secondary outcome:

To assess if Nortriptyline improves quality of life in patients with nonulcer dyspepsia

To assess frequency of side effects in patients receiving Nortriptyline for 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.

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

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: CBC, CMP, TSH, Tissue transglutaminase IgA

- Predominantly GERD symptoms

- Current Helicobacter pylori infection

- History of PUD

- NSAID use > 2x/wk

- Pregnant or planning pregnancy

- History of major depression

- Abdominal surgery in the last year

Fernando Castro, MD, Phone: 954-659-5000, Email: castrof@ccf.org

Cleveland Clinic Florida, Weston, Florida 33331, United States; Recruiting
Fernando Castro, MD, Principal Investigator
Tolga Erim, DO, Sub-Investigator
Einar Lurix, MD, Sub-Investigator
Matthew Thoma, MD, Sub-Investigator
German Gonzalez, MD, Sub-Investigator

Related publications:

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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, 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.

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Starting date: February 2008
Last updated: February 8, 2008