Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

NCT ID: NCT00171418

Last Updated: 2008-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease (GERD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tegaserod

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* GERD symptoms for at least 6 months
* PPI therapy for at least 4 weeks
* Incomplete symptom relief on daily PPI therapy
* No erosive disease as evidenced in EGD/no change in symptom severity

Exclusion Criteria

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
* Previous gastrointestinal surgery that may influence esophageal motor function
* Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
* Evidence of cathartic colon or a history of laxative use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Drug Research Services, Inc

Metairie, Louisiana, United States

Site Status

The Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHTF919BUS26

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.