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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232024
• Other study ID #: CHTF919D2301
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: January 31, 2008
• Start date: January 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1296
• Est. completion date: May 2006
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average severity score during each week.
Secondary	Percentage of days with satisfactory relief of dyspepsia during each week.
Secondary	Weekly global assessment of change in dyspepsia condition.
Secondary	Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Secondary	Quality of life at end of treatment compared to baseline.
Secondary	Safety and tolerability.