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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:
NCT00232089
First received: September 8, 2005
Last updated: August 31, 2010
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 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
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  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

ClinicalTrials.gov Identifier: NCT00232089     History of Changes
Other Study ID Numbers: CHTF919D2302
Study First Received: September 8, 2005
Last Updated: August 31, 2010
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 June 17, 2013