- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171457
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
October 9, 2007 updated by: Novartis
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
Study Overview
Study Type
Interventional
Enrollment
24
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Foundation for Digestive Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects at least 18 years of age.
- Subjects willing to undergo multiple nasogastric intubations.
- Patients with functional heartburn will need to meet ROME II criteria.
- Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)
Exclusion Criteria:
- Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
- Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
- Subjects with Diffuse Esophageal Spasm or Achalasia.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
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Secondary Outcome Measures
Outcome Measure |
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Safety assessment
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1) Comparing effects at end of treatment compared to baseline:
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To verify that tegaserod modulates esophageal sensitivity to esophageal distention
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To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
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To determine if tegaserod improves heartburn and/or regurgitation
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To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
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To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
October 10, 2007
Last Update Submitted That Met QC Criteria
October 9, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHTF919DUS45
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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