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

Completed · Phase 3

Conditions studied: Dyspepsia

In brief

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.

Key facts

Study ID

NCT00232089

Run by

Novartis

People needed

1296

Starts

2004-05-01

Expected to finish

2006-06-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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