Clinical trial NCT00389948: Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Keywords: Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
measure: To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
measure: Evaluation of lansoprazole safety.
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants Inc.
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Sierra Vista
country: United States
facility: Radiant Research
state: Arizona
city: Los Angeles
country: United States
facility: California Bio Medical Research Institute
state: California
city: Roseville
country: United States
facility: Allergy Medical Group of North Area
state: California
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness Inc.
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Reisterstown
country: United States
facility: Clinical Associates
state: Maryland
city: St. Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Rio Rancho
country: United States
facility: William W. Anderson M.D. P.C.
state: New Mexico
city: Port Chester
country: United States
facility: IRSI
state: New York
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Columbus
country: United States
facility: Micheal Alexander, DO
state: Ohio
city: Portland
country: United States
facility: New Hope Research of Oregon
state: Oregon
city: Carnegie
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Johnson City
country: United States
facility: Advanced Therapeutics, Inc
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research
state: Tennessee
city: Dallas
country: United States
facility: Medical Edge Healthcare Group, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Richmond
country: United States
facility: Commonwealth Clinical Research Specialist
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.
state: Virginia
city: Lakewood
country: United States
facility: Radiant Research
state: Washington
Study officials:
References: