Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00701259

First received: June 17, 2008

Last updated: January 13, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 17, 2008
Last Updated Date	January 13, 2010
Start Date ^ICMJE	January 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 18, 2008)	Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00701259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 18, 2008)	Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Official Title ^ICMJE	A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn
Brief Summary	Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Frequent Heartburn
Intervention ^ICMJE	Drug: Lansoprazole Lansoprazole 15 mg once per day for 14 days Other Name: Prevacid - United States Drug: Lansoprazole Lansoprazole 30 mg once per day for 14 days Drug: placebo
Study Arm (s)	Experimental: 1 15 mg lansoprazole Intervention: Drug: Lansoprazole Experimental: 2 30 mg lansoprazole Intervention: Drug: Lansoprazole Placebo Comparator: 3 placebo Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	852
Completion Date	August 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Experiencing heartburn at least 2 days per week during the nighttime period 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/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 Number ^ICMJE	NCT00701259
Other Study ID Numbers ^ICMJE	PRSW-GN-305
Has Data Monitoring Committee	No
Responsible Party	Regulatory Affairs, Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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