NCT00149851

Brief Summary

Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
832

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2

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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 1, 2010

Status Verified

January 1, 2008

Enrollment Period

1.4 years

First QC Date

September 6, 2005

Last Update Submit

August 31, 2010

Conditions

Symptomatic Gastroespohageal Reflux Disease

Keywords

GERD, heartburn, regurgitation, reflux disease

Outcome Measures

Primary Outcomes (4)

  • Proportion of patients experiencing resolution of heart-burn during week 4 of treatment

  • Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

  • Decreasing frequency of regurgitation during week 4 of treatment

  • Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

Interventions

TegaserodDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of physician diagnosed GERD
  • Heartburn and Regurgitation 3 Days during the week prior to screening

You may not qualify if:

  • History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
  • History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
  • Use of PPI during the last four weeks prior to screening

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

Gastroesophageal RefluxHeartburn

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis

    East Hanover NJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

September 1, 2010

Record last verified: 2008-01

Locations

US(1)