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

Phase 3CompletedNCT00232089

Novartis1,296 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,296

Conditions

Dyspepsia

Interventions

TegaserodDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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