Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232024

Purpose

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.

Condition	Intervention	Phase
Dyspepsia	Drug: Tegaserod	Phase III

MedlinePlus related topics: Indigestion Nausea and Vomiting

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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.

Estimated Enrollment:	1296
Study Start Date:	January 2004
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232024

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936-108

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Basel

More Information

Study ID Numbers:	CHTF919D2301
Study First Received:	September 8, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00232024
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dyspepsia, gastrointestinal, tegaserod

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Dyspepsia
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009