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 post-prandial fullness early satiety and bloating)

Secondary Measures

• 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.

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

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 Basel  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232024

Study ID Number: CHTF919D2301

ClinicalTrials.gov Identifier: NCT00232024

Health Authority: United States: Food and Drug Administration