{"protocolSection":{"identificationModule":{"nctId":"NCT00547703","orgStudyIdInfo":{"id":"IRB 8918"},"organization":{"fullName":"The Cleveland Clinic","class":"OTHER"},"briefTitle":"Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia","officialTitle":"Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia"},"statusModule":{"statusVerifiedDate":"2025-10","overallStatus":"TERMINATED","whyStopped":"Not enough participants - only 5 since the study started","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-02"},"primaryCompletionDateStruct":{"date":"2010-04","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2007-10-19","studyFirstSubmitQcDate":"2007-10-19","studyFirstPostDateStruct":{"date":"2007-10-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-20","resultsFirstSubmitQcDate":"2012-06-07","resultsFirstPostDateStruct":{"date":"2012-07-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2026-07-31","lastUpdatePostDateStruct":{"date":"2026-08-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Fernando Castro","investigatorTitle":"Principal investigator","investigatorAffiliation":"The Cleveland Clinic"},"leadSponsor":{"name":"The Cleveland Clinic","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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.\n\nOnce 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.\n\nOur hypothesis is that Nortriptyline will improve symptoms of nonulcer dyspepsia and improve quality of life."},"conditionsModule":{"conditions":["Non Ulcer Dyspepsia"],"keywords":["Nonulcer dyspepsia","Functional dyspepsia","Antidepressant use in dyspepsia","Nortriptyline","Tricyclic antidepressants"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":5,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Nortriptyline","type":"ACTIVE_COMPARATOR","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.","interventionNames":["Drug: Nortriptyline"]},{"label":"Sugar pill","type":"PLACEBO_COMPARATOR","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Nortriptyline","description":"Nortriptyline 25mg capsule, orally administered, every night for 8 weeks","armGroupLabels":["Nortriptyline"],"otherNames":["Pamelor"]},{"type":"DRUG","name":"Placebo","description":"An identical placebo capsule containing lactose, administered orally, every night for 8 weeks","armGroupLabels":["Sugar pill"],"otherNames":["Sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.","description":"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.","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Quality Of Life in Reflux and Dyspepsia (QOLRAD)","description":"Patients were administered the validated QOLRAD (Quality of Life in Reflux and Dyspepsia) questionnaire to assess if nortriptyline improves quality of life in patients with non-ulcer dyspepsia. The total score range is 25 to 175. Higher scores indicate better quality of life.","timeFrame":"8 weeks"},{"measure":"Number of Participants With Side Effects","description":"To assess the number of patients who experienced side effects. Patients were asked about side effects on each office visit and ask to call for significant side effects.","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men and Women\n* Ages 18-65\n* Meet Rome III criteria for functional dyspepsia\n* Endoscopy within 1 year\n\nExclusion Criteria:\n\n* Allergic reaction or history of adverse events with Nortriptyline or tricyclic antidepressants\n* Organic cause found on physical examination\n* Organic cause found on lab work: Complete Blood Count, Comprehensive Metabolic Panel, Thyroid stimulating hormone, Tissue transglutaminase Immunoglobulin A\n* Predominantly Gastroesophageal reflux symptoms\n* Current Helicobacter pylori infection\n* History of Peptic ulcer disease\n* Non steroidal antiinflammatory use use \\> 2x/wk\n* Pregnant or planning pregnancy\n* History of major depression\n* Abdominal surgery in the last year","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Fernando Castro, MD","affiliation":"Cleveland Clinic Florida","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Cleveland Clinic Florida","city":"Weston","state":"Florida","zip":"33331","country":"United States","geoPoint":{"lat":26.10037,"lon":-80.39977}}]},"referencesModule":{"references":[{"pmid":"9468233","type":"BACKGROUND","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. doi: 10.1111/j.1572-0241.1998.00160.x."},{"pmid":"8726297","type":"BACKGROUND","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. doi: 10.3109/00365529609006404."},{"pmid":"10027672","type":"BACKGROUND","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":"16441473","type":"BACKGROUND","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. doi: 10.1111/j.1365-2036.2006.02774.x."},{"pmid":"16322947","type":"BACKGROUND","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. doi: 10.1007/s00535-005-1687-8."},{"pmid":"8677926","type":"BACKGROUND","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":"16181387","type":"BACKGROUND","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. doi: 10.1111/j.1572-0241.2005.00225.x."},{"pmid":"11059442","type":"BACKGROUND","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. doi: 10.1016/s0002-9343(99)00299-5."},{"pmid":"11276271","type":"BACKGROUND","citation":"Talley NJ. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 2001 Apr;32(4):286-93. doi: 10.1097/00004836-200104000-00004."},{"pmid":"11467624","type":"BACKGROUND","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. doi: 10.1111/j.1572-0241.2001.03932.x."},{"pmid":"16678567","type":"BACKGROUND","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. doi: 10.1053/j.gastro.2005.11.058."},{"pmid":"10457048","type":"BACKGROUND","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(Suppl 2):II69-77. doi: 10.1136/gut.45.2008.ii69."},{"pmid":"15521002","type":"BACKGROUND","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. doi: 10.1053/j.gastro.2004.08.026."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks."},{"id":"FG001","title":"Placebo","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks."},{"id":"BG001","title":"Placebo","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"10"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"42","spread":"4"},{"groupId":"BG001","value":"43","spread":"0"},{"groupId":"BG002","value":"42","spread":"4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.","description":"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.","populationDescription":"All patients who completed the 8 weeks of the study","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks."},{"id":"OG001","title":"Placebo","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Quality Of Life in Reflux and Dyspepsia (QOLRAD)","description":"Patients were administered the validated QOLRAD (Quality of Life in Reflux and Dyspepsia) questionnaire to assess if nortriptyline improves quality of life in patients with non-ulcer dyspepsia. The total score range is 25 to 175. Higher scores indicate better quality of life.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.\n\nNortriptyline: Nortriptyline 25mg capsule, orally administered, every night for 8 weeks"},{"id":"OG001","title":"Sugar Pill","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks.\n\nPlacebo: An identical placebo capsule containing lactose, administered orally, every night for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"classes":[{"title":"Week 0","categories":[{"measurements":[{"groupId":"OG000","value":"71","lowerLimit":"44","upperLimit":"98"},{"groupId":"OG001","value":"121","lowerLimit":"121","upperLimit":"121"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"163","lowerLimit":"151","upperLimit":"175"},{"groupId":"OG001","value":"164","lowerLimit":"164","upperLimit":"164"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Side Effects","description":"To assess the number of patients who experienced side effects. Patients were asked about side effects on each office visit and ask to call for significant side effects.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks."},{"id":"OG001","title":"Placebo","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Nortriptyline","description":"Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.","seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":2,"otherNumAtRisk":3},{"id":"EG001","title":"Placebo","description":"Patients in this group will receive an identical placebo capsule at night for 8 weeks.","seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":1,"otherNumAtRisk":1}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":3},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":1}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We were unable to recruit an adequate number of patients to make any meaningful conclusion."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Fernando Castro","organization":"Cleveland Clinic Florida","email":"castrof@ccf.org","phone":"954-659-5646"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2015-10-05","uploadDate":"2026-07-31T16:04","filename":"Prot_SAP_000.pdf","size":1622507},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2015-10-05","uploadDate":"2026-07-31T16:07","filename":"ICF_001.pdf","size":1405538}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D009661","term":"Nortriptyline"},{"id":"D000073893","term":"Sugars"}],"ancestors":[{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D002241","term":"Carbohydrates"}]}},"hasResults":true}