Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Tegaserod

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