Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

NCT ID: NCT00389948

Last Updated: 2007-04-16

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-01-31

Brief Summary

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Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.

Detailed Description

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Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lanzoprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Experiencing heartburn at least 2 days per week over the past month.
2. Having heartburn that responds to heartburn medication.
3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria

1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
2. Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Locations

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Clinical Research Consultants Inc.

Hoover, Alabama, United States

Site Status

Huntsville, Alabama, United States

Site Status

Radiant Research

Sierra Vista, Arizona, United States

Site Status

California Bio Medical Research Institute

Los Angeles, California, United States

Site Status

Allergy Medical Group of North Area

Roseville, California, United States

Site Status

Eastern Research

Hialeah, Florida, United States

Site Status

Health Awareness Inc.

Jupiter, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Radiant Research

Atlanta, Georgia, United States

Site Status

Radiant Research

Atlanta, Georgia, United States

Site Status

Evansville, Indiana, United States

Site Status

Clinical Associates

Reisterstown, Maryland, United States

Site Status

Medex Healthcare Research, Inc.

St Louis, Missouri, United States

Site Status

Meridian Clinical Research LLC

Omaha, Nebraska, United States

Site Status

William W. Anderson M.D. P.C.

Rio Rancho, New Mexico, United States

Site Status

IRSI

Port Chester, New York, United States

Site Status

Crescent Medical Research

Salisbury, North Carolina, United States

Site Status

Micheal Alexander, DO

Columbus, Ohio, United States

Site Status

New Hope Research of Oregon

Portland, Oregon, United States

Site Status

Preferred Primary Care Physicians

Carnegie, Pennsylvania, United States

Site Status

Advanced Therapeutics, Inc

Johnson City, Tennessee, United States

Site Status

Nashville Medical Research

Nashville, Tennessee, United States

Site Status

Medical Edge Healthcare Group, P.A.

Dallas, Texas, United States

Site Status

Benchmark Research

Fort Worth, Texas, United States

Site Status

Benchmark Research

San Angelo, Texas, United States

Site Status

Commonwealth Clinical Research Specialist

Richmond, Virginia, United States

Site Status

National Clinical Research Inc.

Richmond, Virginia, United States

Site Status

Radiant Research

Lakewood, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PRSW-GN-301

Identifier Type: -

Identifier Source: org_study_id