Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00389948 |
Recruitment Status :
Completed
First Posted : October 19, 2006
Last Update Posted : April 16, 2007
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Sponsor:
Novartis
Information provided by:
Novartis
Tracking Information | |||
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First Submitted Date ICMJE | October 18, 2006 | ||
First Posted Date ICMJE | October 19, 2006 | ||
Last Update Posted Date | April 16, 2007 | ||
Study Start Date ICMJE | June 2006 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE |
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 | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
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 | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Heartburn | ||
Intervention ICMJE | Drug: Lanzoprazole | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
576 | ||
Original Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | January 2007 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion or exclusion criteria may apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00389948 | ||
Other Study ID Numbers ICMJE | PRSW-GN-301 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Novartis | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Novartis | ||
Verification Date | April 2007 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |