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

Tracking Information
First Received Date ^ICMJE	October 18, 2006
Last Updated Date	April 13, 2007
Start Date ^ICMJE	June 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 18, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00389948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 18, 2006)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Heartburn
Intervention ^ICMJE	Drug: Lanzoprazole
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	576
Completion Date	January 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00389948
Responsible Party
Study ID Numbers ^ICMJE	PRSW-GN-301
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	April 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP