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Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

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ClinicalTrials.gov Identifier: NCT00389948
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : April 16, 2007
Sponsor:
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heartburn Drug: Lanzoprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
  2. To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
  3. Evaluation of lansoprazole safety.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389948


Locations
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Sponsors and Collaborators
Novartis
More Information
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ClinicalTrials.gov Identifier: NCT00389948    
Other Study ID Numbers: PRSW-GN-301
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: April 16, 2007
Last Verified: April 2007
Keywords provided by Novartis:
Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
Additional relevant MeSH terms:
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Heartburn
Signs and Symptoms, Digestive