A Phase 3 interventional study of Tegaserod in Dyspepsia, sponsored by Novartis. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 1,296 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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)
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.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Novartis