Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyspepsia
Intervention: Tegaserod (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Basel
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.
Clinical Details
Official title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
Secondary outcome: Average severity score during each week.Percentage of days with satisfactory relief of dyspepsia during each week. Weekly global assessment of change in dyspepsia condition. Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. Quality of life at end of treatment compared to baseline. Safety and tolerability.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female, 18 years or 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 upper GI endoscopy findings such as esophageal, gastric erosions or ulcers
and/or duodenal ulcers/erosions.
- Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.
Other protocol-defined inclusion/exclusion criteria may appl
Locations and Contacts
Novartis, East Hanover, New Jersey 07936-108, United States
Additional Information
Starting date: January 2004
Ending date: May 2006
Last updated: January 31, 2008
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