NCT00171470

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

September 12, 2005

Last Update Submit

January 31, 2008

Conditions

Dyspepsia

Keywords

dyspepsiahearburnfemalePPI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

TegaserodDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go

East Hanover, New Jersey, 07936, United States

Location

Related Links

MeSH Terms

Conditions

Dyspepsia

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Study Completion

August 1, 2006

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

US(1)