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

Non Ulcer Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547703
• Other study ID #: IRB 8918
• Status: Terminated
• Phase: N/A
• First received: October 19, 2007
• Last updated: June 7, 2012
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2012
• Source: Cleveland Clinic Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Dyspepsia
• Non Ulcer Dyspepsia

Intervention

Drug:
• Nortriptyline
Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
• Placebo
An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

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

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. — View 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:II69-77. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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	8 weeks	No
Secondary	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.	8 weeks	Yes