Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-25 @ 4:09 PM
Study NCT ID:
NCT00171457
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006356', 'term': 'Heartburn'}, {'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105050', 'term': 'tegaserod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach'}], 'secondaryOutcomes': [{'measure': '1) Comparing effects at end of treatment compared to baseline:'}, {'measure': 'To verify that tegaserod modulates esophageal sensitivity to esophageal distention'}, {'measure': 'To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort'}, {'measure': 'To determine if tegaserod improves heartburn and/or regurgitation'}, {'measure': 'To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo'}, {'measure': 'Safety assessment'}, {'measure': 'To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi'}]}, 'conditionsModule': {'keywords': ['functional heartburn', 'dyspepsia', 'male', 'female', 'visceral sensitivity'], 'conditions': ['Heartburn', 'Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '18561877', 'type': 'DERIVED', 'citation': 'Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects at least 18 years of age.\n* Subjects willing to undergo multiple nasogastric intubations.\n* Patients with functional heartburn will need to meet ROME II criteria.\n* Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)\n\nExclusion Criteria:\n\n* Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.\n* Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.\n* Subjects with Diffuse Esophageal Spasm or Achalasia.\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00171457', 'briefTitle': 'The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.', 'orgStudyIdInfo': {'id': 'CHTF919DUS45'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}