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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 8, 2005
Last updated: January 31, 2008
Last verified: January 2008
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female

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

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Please refer to this study by its identifier: NCT00232024

United States, New Jersey
East Hanover, New Jersey, United States, 07936-108
Sponsors and Collaborators
Study Chair: Novartis Basel
  More Information Identifier: NCT00232024     History of Changes
Other Study ID Numbers: CHTF919D2301
Study First Received: September 8, 2005
Last Updated: January 31, 2008

Keywords provided by Novartis:
Dyspepsia, gastrointestinal, tegaserod

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on June 23, 2017