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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00232024
First received: September 8, 2005
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Novartis:
Dyspepsia, gastrointestinal, tegaserod

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013