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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.
Information provided by:
Novartis Identifier:
First received: September 12, 2005
Last updated: January 31, 2008
Last verified: January 2008
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
Drug: Tegaserod
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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

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

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.

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Please refer to this study by its identifier: NCT00171470

United States, New Jersey
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information Identifier: NCT00171470     History of Changes
Other Study ID Numbers: CHTF919DUS46
Study First Received: September 12, 2005
Last Updated: January 31, 2008

Keywords provided by Novartis:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on April 28, 2017