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:	NCT00232089

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 postprandial fullness early satiety and bloating)

Secondary Outcome 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.

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

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232089

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

East Hanover NJ

More Information

No publications provided

Study ID Numbers:	CHTF919D2302
Study First Received:	September 8, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00232089 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Dyspepsia, gastrointestinal, tegaserod

Study placed in the following topic categories:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Signs and Symptoms, Digestive

Dyspepsia
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Signs and Symptoms
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Signs and Symptoms, Digestive
Physiological Effects of Drugs
Dyspepsia
Pharmacologic Actions
Tegaserod

ClinicalTrials.gov processed this record on May 07, 2009