Expired Study
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Weston, Florida 33331


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.


Study summary:

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.


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


Study is Available At:


Original ID:

IRB 8918


NCT ID:

NCT00547703


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cleveland Clinic Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Not enough participants - only 7 since the s


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

72


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Fernando Castro, MD
Principal Investigator
Cleveland Clinic Florida

Study Dates

Start Date:February 2008
Completion Date:June 2010
Completion Type:Actual
Verification Date:January 2009
Last Changed Date:June 2, 2010
First Received Date:October 19, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia
Time Frame:8 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To assess if Nortriptyline improves quality of life in patients with nonulcer dyspepsia
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To assess if Nortriptyline improves abdominal pain/discomfort in patients with nonulcer dyspepsia
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Nortriptyline
Description:Nortriptyline 25mg capsule, orally administered, every night for 8 weeks
Arm Name:A
Intervention Type:Drug
Name:Placebo
Description:An identical placebo capsule containing lactose, administered orally, every night for 8 weeks
Arm Name:B

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:B
Description:Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Study Arm Type:Active Comparator
Arm Name:A
Description:Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Cleveland Clinic Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:9468233
Reference Type:Reference
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.
PMID:8726297
Reference Type:Reference
Citation: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
Reference Type:Reference
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.
PMID:16441473
Reference Type:Reference
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.
PMID:16322947
Reference Type:Reference
Citation: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
Reference Type:Reference
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.
PMID:16181387
Reference Type:Reference
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.
PMID:11059442
Reference Type:Reference
Citation:Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001 Apr;32(4):286-93. Review.
PMID:11276271
Reference Type:Reference
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.
PMID:11467624
Reference Type:Reference
Citation: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.
PMID:16678567
Reference Type:Reference
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.
PMID:10457048
Reference Type:Reference
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.
PMID:15521002

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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