NCT00232024

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,296

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

First QC Date

September 8, 2005

Last Update Submit

January 31, 2008

Conditions

Dyspepsia

Keywords

Dyspepsia, gastrointestinal, tegaserod

Outcome Measures

Primary Outcomes (1)

  • Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)

Secondary Outcomes (6)

  • Average severity score during each week.

  • Percentage of days with satisfactory relief of dyspepsia during each week.

  • Weekly global assessment of change in dyspepsia condition.

  • Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.

  • Quality of life at end of treatment compared to baseline.

  • +1 more secondary outcomes

Interventions

TegaserodDRUG

Eligibility Criteria

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

You may qualify if:

  • Female, 18 years or 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.

You may not qualify if:

  • Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
  • Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936-108, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

tegaserod

Condition Hierarchy (Ancestors)

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

Study Officials

  • Novartis

    Basel

    STUDY CHAIR

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 8, 2005

First Posted

October 4, 2005

Study Start

January 1, 2004

Study Completion

May 1, 2006

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

US(1)