Clinical trial NCT00390390: 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: Mobile
country: United States
facility: Sunbelt Research Group
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic
state: Alaska
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research - Scottsdale
state: Arizona
city: Fountain Valley
country: United States
facility: Edinger Medical Group
state: California
city: San Diego
country: United States
facility: Gaslamp Medical Center
state: California
city: Colorado Springs
country: United States
facility: Expresscare Clinical Research
state: Colorado
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials inc.
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: Rockland
country: United States
facility: IRSI
state: Massachusetts
city: St. Louis
country: United States
facility: Prime Care Research
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: South Bound Brook
country: United States
facility: Urgentmed
state: New Jersey
city: Raleigh
country: United States
facility: Wake research associates, Inc
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute For Health Awareness
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Durham
country: United States
facility: Durham Physicans
state: Pennsylvania
city: Nashville
country: United States
facility: 2222 State Street
state: Tennessee
city: Austin
country: United States
facility: Wells Branch Medical Center
state: Texas
city: Dallas
country: United States
facility: Medical Edge Healthcare Group
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
facility: Clinical Trials Network
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Weber City
country: United States
facility: Holston Medical Group
state: Virginia
Study officials:
References: