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

NCT00547703 | Terminated Results

• 1 other identifier: IRB 8918
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Ulcer Dyspepsia

Keywords

Nonulcer dyspepsia; Functional dyspepsia; Antidepressant use in dyspepsia; Nortriptyline; Tricyclic antidepressants

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• QOLRAD Questionaire for Patients With Upper Abdominal Symptoms

  8 weeks

• Side Effects

  8 weeks

Study Arms (2)

Nortriptyline

ACTIVE COMPARATOR

Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.

Drug: Nortriptyline

Sugar pill

PLACEBO COMPARATOR

Patients in this group will receive an identical placebo capsule at night for 8 weeks.

Drug: Placebo

Interventions

Nortriptyline DRUG

Nortriptyline 25mg capsule, orally administered, every night for 8 weeks

Also known as: Pamelor

Nortriptyline

Placebo DRUG

An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women
• Ages 18-65
• Meet Rome III criteria for functional dyspepsia
• Endoscopy within 1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (13)

• 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.

  PMID: 9468233 BACKGROUND

• 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.

  PMID: 8726297 BACKGROUND

• 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.

  PMID: 10027672 BACKGROUND

• 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.

  PMID: 16441473 BACKGROUND

• 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.

  PMID: 16322947 BACKGROUND

• 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.

  PMID: 8677926 BACKGROUND

• 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.

  PMID: 16181387 BACKGROUND

• 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.

  PMID: 11059442 BACKGROUND

• Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001 Apr;32(4):286-93. doi: 10.1097/00004836-200104000-00004.

  PMID: 11276271 BACKGROUND

• 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.

  PMID: 11467624 BACKGROUND

• 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.

  PMID: 16678567 BACKGROUND

• 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.

  PMID: 10457048 BACKGROUND

• 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.

  PMID: 15521002 BACKGROUND

MeSH Terms

Interventions

Nortriptyline; Sugars

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

We were unable to recruit an adequate number of patients to make any meaningful conclusion.

Results Point of Contact

• Title: Fernando Castro
• Organization: Cleveland Clinic Florida

castrof@ccf.org

954-659-5646

Study Officials

• Fernando Castro, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: February 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 17, 2017
• Results First Posted: July 10, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)