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

Sponsor:	Cleveland Clinic Florida
Information provided by:	Cleveland Clinic Florida
ClinicalTrials.gov Identifier:	NCT00547703

Purpose

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.

Condition	Intervention
Non Ulcer Dyspepsia	Drug: Nortriptyline Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Antidepressants Indigestion

Drug Information available for: Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:

To assess if Nortriptyline improves abdominal pain/discomfort in patients with nonulcer dyspepsia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess if Nortriptyline improves quality of life in patients with nonulcer dyspepsia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	February 2008

Arms	Assigned Interventions
A: Active Comparator Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.	Drug: Nortriptyline Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
B: Placebo Comparator Patients in this group will receive an identical placebo capsule at night for 8 weeks.	Drug: Placebo An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547703

Contacts

Contact: Fernando Castro, MD	954-659-5000	castrof@ccf.org
Contact: Tolga Erim, DO	954-659-5000	erimt@ccf.org

Locations

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

Sponsors and Collaborators

Cleveland Clinic Florida

Investigators

Principal Investigator:

Fernando Castro, MD

Cleveland Clinic Florida

More Information

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, 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.

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.

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.

Responsible Party:	Cleveland Clinic Florida ( Fernando Castro, MD, Principle Investigator )
Study ID Numbers:	IRB 8918
Study First Received:	October 19, 2007
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00547703 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:

Nonulcer dyspepsia
Functional dyspepsia
Antidepressant use in dyspepsia
Nortriptyline
Tricyclic antidepressants

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Signs and Symptoms, Digestive
Adrenergic Uptake Inhibitors
Abdominal Pain
Gastrointestinal Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Pain
Dyspepsia

Pharmacologic Actions
Antidepressive Agents, Tricyclic
Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Nortriptyline
Gastroenteritis
Central Nervous System Agents
Gastritis
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009