Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00389948

Purpose

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.

Condition	Intervention	Phase
Heartburn	Drug: Lanzoprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn

Resource links provided by NLM:

MedlinePlus related topics: Heartburn

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.

Secondary Outcome Measures:

To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Evaluation of lansoprazole safety.

Estimated Enrollment:	576
Study Start Date:	June 2006
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion or exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389948

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Locations

United States, Alabama
Clinical Research Consultants Inc.
Hoover, Alabama, United States, 35216

Huntsville, Alabama, United States, 35802
United States, Arizona
Radiant Research
Sierra Vista, Arizona, United States, 85635
United States, California
California Bio Medical Research Institute
Los Angeles, California, United States, 90025
Allergy Medical Group of North Area
Roseville, California, United States, 95678
United States, Florida
Eastern Research
Hialeah, Florida, United States, 33013
Miami Research Associates
Miami, Florida, United States, 33173
Health Awareness Inc.
Jupiter, Florida, United States, 33458
United States, Georgia
Radiant Research
Atlanta, Georgia, United States, 30252
Radiant Research
Atlanta, Georgia, United States, 30308
United States, Indiana

Evansville, Indiana, United States, 47714
United States, Maryland
Clinical Associates
Reisterstown, Maryland, United States, 21136
United States, Missouri
Medex Healthcare Research, Inc.
St. Louis, Missouri, United States, 63117
United States, Nebraska
Meridian Clinical Research LLC
Omaha, Nebraska, United States, 68134
United States, New Mexico
William W. Anderson M.D. P.C.
Rio Rancho, New Mexico, United States, 87124
United States, New York
IRSI
Port Chester, New York, United States, 10573
United States, North Carolina
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
United States, Ohio
Micheal Alexander, DO
Columbus, Ohio, United States, 43204
United States, Oregon
New Hope Research of Oregon
Portland, Oregon, United States, 97219
United States, Pennsylvania
Preferred Primary Care Physicians
Carnegie, Pennsylvania, United States, 15106
United States, Tennessee
Advanced Therapeutics, Inc
Johnson City, Tennessee, United States, 37601
Nashville Medical Research
Nashville, Tennessee, United States, 37205
United States, Texas
Medical Edge Healthcare Group, P.A.
Dallas, Texas, United States, 75243
Benchmark Research
San Angelo, Texas, United States, 76904
Benchmark Research
Fort Worth, Texas, United States, 76135
United States, Virginia
Commonwealth Clinical Research Specialist
Richmond, Virginia, United States, 23226
National Clinical Research Inc.
Richmond, Virginia, United States, 23294
United States, Washington
Radiant Research
Lakewood, Washington, United States, 98499

Sponsors and Collaborators

Novartis

More Information

Additional Information:

NA

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	PRSW-GN-301
Study First Received:	October 18, 2006
Last Updated:	April 13, 2007
ClinicalTrials.gov Identifier:	NCT00389948 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole

Additional relevant MeSH terms:

Anti-Infective Agents
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Heartburn
Enzyme Inhibitors
Lansoprazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009