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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00232089
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dyspepsia Drug: Tegaserod Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study Start Date : May 2004
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Weekly assessment of satisfactory relief of dyspepsia.
  2. Daily assessment of percentage of patients responding on average severity score.
  3. For each week assessment of average daily severity score.
  4. Percentage of days with satisfactory relief of dyspepsia during each week.
  5. Weekly global assessment of change in dyspepsia condition.
  6. Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
  7. Quality of life at end of treatment compared to baseline.
  8. Safety and tolerability.

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00232089     History of Changes
Other Study ID Numbers: CHTF919D2302
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

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
Physiological Effects of Drugs