Back to resultsAssessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tegaserod
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, gastrointestinal, tegaserod
Eligibility Criteria
Inclusion Criteria: Female patients, 18 years and older Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months. Exclusion Criteria: Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline. Current or history of erosive esophagitis confirmed by EGD Heartburn occurring 3 or more days a week. Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
Secondary Outcome Measures
Weekly assessment of satisfactory relief of dyspepsia.
Daily assessment of percentage of patients responding on average severity score.
For each week assessment of average daily severity score.
Percentage of days with satisfactory relief of dyspepsia during each week.
Weekly global assessment of change in dyspepsia condition.
Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Quality of life at end of treatment compared to baseline.
Safety and tolerability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232089
Brief Title
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Official Title
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Dyspepsia, gastrointestinal, tegaserod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1296 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod
Primary Outcome Measure Information:
Title
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
Secondary Outcome Measure Information:
Title
Weekly assessment of satisfactory relief of dyspepsia.
Title
Daily assessment of percentage of patients responding on average severity score.
Title
For each week assessment of average daily severity score.
Title
Percentage of days with satisfactory relief of dyspepsia during each week.
Title
Weekly global assessment of change in dyspepsia condition.
Title
Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Title
Quality of life at end of treatment compared to baseline.
Title
Safety and tolerability.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Female patients, 18 years and older
Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.
Exclusion Criteria:
Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.
Current or history of erosive esophagitis confirmed by EGD
Heartburn occurring 3 or more days a week.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
East Hanover NJ
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936-108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18616658
Citation
Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol. 2008 Aug;103(8):1906-19. doi: 10.1111/j.1572-0241.2008.01953.x. Epub 2008 Jul 4.
Results Reference
result
Learn more about this trial
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
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