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NCT00390390 Clinical Trial

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00390390
Other study ID # PRSW-GN-302
Secondary ID
Status Completed
Phase Phase 3
First received October 18, 2006
Last updated May 24, 2010
Start date June 2006
Est. completion date January 2007

Study information
Verified date April 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 576
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Other protocol-defined inclusion or exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lansoprazole

Locations
Country Name City State
United States Central Florida Clinical Trials inc. Altamonte Springs Florida
United States Wells Branch Medical Center Austin Texas
United States Radiant Research Chandler Arizona
United States Radiant Research Cincinnati Ohio
United States Tampa Bay Medical Research, Inc. Clearwater Florida
United States Expresscare Clinical Research Colorado Springs Colorado
United States Medical Edge Healthcare Group Dallas Texas
United States Durham Physicans Durham Pennsylvania
United States Edinger Medical Group Fountain Valley California
United States Clinical Trials Network Houston Texas
United States Health Awareness Inc. Jupiter Florida
United States Wells Institute For Health Awareness Kettering Ohio
United States Clinical Research Center of Nevada Las Vegas Nevada
United States Arkansas Primary Care Clinic Little Rock Alaska
United States Sunbelt Research Group Mobile Alabama
United States 2222 State Street Nashville Tennessee
United States Health Research of Hampton Roads Newport News Virginia
United States University Clinical Research, Inc. Pembroke Pines Florida
United States Accelovance Peoria Illinois
United States Wake research associates, Inc Raleigh North Carolina
United States IRSI Rockland Massachusetts
United States Gaslamp Medical Center San Diego California
United States Radiant Research - Scottsdale Scottsdale Arizona
United States Urgentmed South Bound Brook New Jersey
United States Prime Care Research St. Louis Missouri
United States Toledo Center for Clinical Research Sylvania Ohio
United States Holston Medical Group Weber City Virginia
United States Palm Beach Research West Palm Beach Florida
United States Piedmont Medical Research Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
Secondary To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Secondary Evaluation of lansoprazole safety.
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