Official Title: “Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary 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 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.

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair East Hanover NJ  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232089

Study ID Number: CHTF919D2302

ClinicalTrials.gov Identifier: NCT00232089

Health Authority: United States: Food and Drug Administration