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The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171470
First received: September 12, 2005
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  Purpose

Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.


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: The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)

Secondary Outcome Measures:
  • Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
  • Quality of Life (weekly assessment)
  • Safety and tolerability

Estimated Enrollment: 60
Study Start Date: April 2005
Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Female patients 18 years or older.
  • Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
  • Stable dose PPI therapy of at least 4 weeks

Exclusion Criteria:

  • History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
  • Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
  • With a current most bothersome symptom of heartburn.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171470

Locations
United States, New Jersey
http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Novartis patient recruitment website  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00171470     History of Changes
Other Study ID Numbers: CHTF919DUS46
Study First Received: September 12, 2005
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
dyspepsia
hearburn
female
PPI

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

ClinicalTrials.gov processed this record on May 23, 2013